NIRA Laser

GUDID 00860296000142

The NIRA Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for charging, factory programming setup and factory diagnosis of returned devices). The NIRA Laser is used for treatment of periorbital wrinkles.

DERMAL PHOTONICS CORPORATION

Laser skin surface treatment system applicator Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece Dermatological laser beam guiding handpiece

• Primary Device ID: 00860296000142
• NIH Device Record Key: 6f9586df-4255-4ea6-8f6a-4fd5ad78ac0b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIRA Laser
• Version Model Number: 104-000
• Company DUNS: 079208137
• Company Name: DERMAL PHOTONICS CORPORATION
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Operating and Storage Conditions

• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit
• Handling Environment Temperature: Between -40 Degrees Fahrenheit and 122 Degrees Fahrenheit
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 100 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -4 Degrees Fahrenheit and 95 Degrees Fahrenheit

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860296000142 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K163137

FDA Product Code

• OHS: Light Based Over The Counter Wrinkle Reduction

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-03
• Device Publish Date: 2019-04-25

Devices Manufactured by DERMAL PHOTONICS CORPORATION

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• 00860296000142 - NIRA Laser: 2019-05-03The NIRA Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consists of a hand piece, wall-plug battery charger, and 1.5 foot USB cable. The hand piece fits in the hand and the laser light comes out of the tip. There is a single micro-USB connector interface that provides two functions: battery charging and USB communication (for charging, factory programming setup and factory diagnosis of returned devices). The NIRA Laser is used for treatment of periorbital wrinkles.
• 00860296000142 - NIRA Laser: 2019-05-03 The NIRA Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA Laser consi