NIRA Bundle (Pro Gen 3, Champagne)

GUDID 00850020752591

The NIRA Laser Bundle is a set of hand-held reusable OTC non-fractional diode laser devices employing 1450 nm wavelength. The NIRA Lasesr consists of a 2 hand pieces, wall charger and 1.5 foot USB cable. The hand pieces fits in the hand and the laser light comes out of the tip. There is a single USB C connector interface that provides battery charging. The NIRA Lasers is used for treatment of periorbital wrinkles.

Nira Innovations Incorporated

Dermatological laser beam guiding handpiece

• Primary Device ID: 00850020752591
• NIH Device Record Key: a6993e57-d777-4599-816e-f73baffb550a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NIRA Bundle (Pro Gen 3, Champagne)
• Version Model Number: 181-000-C02
• Company DUNS: 079208137
• Company Name: Nira Innovations Incorporated
• 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: false
• 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

Customer Support Contacts

• Phone: 8776076472
• Email: info@niraskin.com
• Phone: 8776076472
• Email: info@niraskin.com
• Phone: 8776076472
• Email: info@niraskin.com
• Phone: 8776076472
• Email: info@niraskin.com

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Degrees Celsius and 100 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Degrees Celsius and 100 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Degrees Celsius and 100 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Degrees Celsius and 100 Degrees Celsius
• Storage Environment Temperature: Between -20 Degrees Celsius and 35 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850020752591 [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: 2025-12-16
• Device Publish Date: 2025-12-08

Devices Manufactured by Nira Innovations Incorporated

• 00850020752263 - NIRA Bundle (Pro Gen 3, White): 2025-12-16 The NIRA Laser Bundle is a set of hand-held reusable OTC non-fractional diode laser devices employing 1450 nm wavelength. The N
• 00850020752430 - NIRA Pro (Gen 3,white): 2025-12-16 The NIRA PRO Gen 3 is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO Gen
• 00850020752447 - NIRA Precision Laser: 2025-12-16 The NIRA Precision Laser is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA L
• 00850020752560 - NIRA Pro+ (Champagne): 2025-12-16 The NIRA PRO+ is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO+ consists
• 00850020752577 - NIRA Pro (Gen 3,Champagne): 2025-12-16 The NIRA PRO Gen 3 is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO Gen
• 00850020752584 - NIRA Bundle (Gen 2 Pro, Champagne): 2025-12-16 The NIRA Laser Bundle is a set of hand-held reusable OTC non-fractional diode laser devices employing 1450 nm wavelength. The N
• 00850020752591 - NIRA Bundle (Pro Gen 3, Champagne): 2025-12-16The NIRA Laser Bundle is a set of hand-held reusable OTC non-fractional diode laser devices employing 1450 nm wavelength. The NIRA Lasesr consists of a 2 hand pieces, wall charger and 1.5 foot USB cable. The hand pieces fits in the hand and the laser light comes out of the tip. There is a single USB C connector interface that provides battery charging. The NIRA Lasers is used for treatment of periorbital wrinkles.
• 00850020752591 - NIRA Bundle (Pro Gen 3, Champagne): 2025-12-16 The NIRA Laser Bundle is a set of hand-held reusable OTC non-fractional diode laser devices employing 1450 nm wavelength. The N
• 00850020752454 - NIRA Pro+: 2025-01-03 The NIRA PRO+ is a hand-held reusable OTC non-fractional diode laser device employing 1450 nm wavelength. The NIRA PRO+ consists