# K222221: Deka Helix

- Pathway: 510(k) (Traditional)
- Applicant: El.En Electronic Engineering Spa
- Decided: Jan 4, 2023 after 163 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K910422 (1992). 328 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203441: The Alma Hybrid Laser System, Alma Lasers, Ltd. (2021) Summary page 6.

## Most influential descendants
- K241092: Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (2024), 0 descendants of its own

## Indications for use
The Helix Laser System with its accessories is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). CO2 Handpieces The Helix CO2 handpieces with wavelength of 10600 nm are indicated for use for the particular indications as follows: Dermatology & Plastic Surgery The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of: * laser skin resurfacing * laser derm-abrasion * laser burn debridement. Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts. Scanning unit The Helix Scanning unit, with wavelength of 10600 nm is indicated for: •Laser skin resurfacing (ablation and/or vaporization) of soft tissue The Helix Scanning unit, with wavelength of 1570 nm, is indicated for: • Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Helix Scanning unit, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

Source page: https://510kreport.com/device/K222221
Methodology: https://510kreport.com/methodology