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Deka Helix

FDA UDI

Class II (US FDA UDI)

by El.en. Spa

Identity

Trade Name
DEKA HELIX FDA UDI
Generic Name
General/multiple surgical diode/carbon dioxide laser system FDA UDI
Device Name
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) FDA UDI
Model / Reference
M133A1 FDA UDI
Description
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) FDA UDI

Identifiers

Catalog Number
M133A1 FDA UDI
Primary DI / UDI-DI
08057017760665 FDA UDI
510(k) Number
K222221 FDA UDI
FDA Product Code
GEX FDA UDI
GMDN Term
General/multiple surgical diode/carbon dioxide laser system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
878.4810 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

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

Deka Helix by El.en. Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as General/multiple surgical diode/carbon dioxide laser system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
El.en. Spa

Sources (1)

  • FDA UDI 0be33bc8-c8f4-48a2-b3c3-b7530ace045c 36 fields · synced Jun 9, 2026