DEKA HELIX M133A1

GUDID 08057017760665

The Helix system consists of: • Laser system console (containing the optical bench assembly and laser, the microcontroller control electronics and system software, the high voltage power supply, the laser cooling system, the compressed air-purge system, and the service panel) • LCD control panel with touch-screen technology: the LCD display provides information on the status and settings of the Helix system with touch-screen technology provided to input commands into the system. • Two wavelengths – CO2 and 1570 nm • Articulated arm • Footswitch • Delivery devices (CO2 non-fractional applicators, Scanner CO2/1570nm fractional applicator)

EL.EN. SPA

General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system General/multiple surgical diode/carbon dioxide laser system

• Primary Device ID: 08057017760665
• NIH Device Record Key: 0be33bc8-c8f4-48a2-b3c3-b7530ace045c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: DEKA HELIX
• Version Model Number: M133A1
• Catalog Number: M133A1
• Company DUNS: 436887608
• Company Name: EL.EN. SPA
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity
• Storage Environment Temperature: Between -10 Degrees Celsius and 50 Degrees Celsius
• Handling Environment Temperature: Between 15 Degrees Celsius and 35 Degrees Celsius
• Handling Environment Humidity: Between 20 Percent (%) Relative Humidity and 80 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Humidity: Between 10 Percent (%) Relative Humidity and 90 Percent (%) Relative Humidity

Device Identifiers

Device Issuing Agency	Device ID
GS1	08057017760665 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K222221

FDA Product Code

• GEX: Powered Laser Surgical Instrument

Sterilization

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

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

[08057017760665]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-03-29
• Device Publish Date: 2023-03-21

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