# K203441: The Alma Hybrid Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Alma Lasers, Ltd.
- Decided: Jul 2, 2021 after 221 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: 20 generations back to K910422 (1992). 327 ancestors in all.
5 later devices descend from it; 4 cite it directly.
0 of 333 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103501: Alma Lasers Pixel CO2 Laser System, Delivery Device and Accessories, Alma Lasers, Inc. (2011) Summary page 5.
- K170060: M22 and ResurFx Systems, Lumenis, Ltd. (2017) Summary page 5.

## Most influential descendants
- K233024: Alma Harmony (2024), 1 descendant of its own
- K222221: Deka Helix (2023), 1 descendant of its own
- K252561: BTL-754FF (2026), 0 descendants of its own
- K251230: The Alma Hybrid Laser System (2025), 0 descendants of its own
- K241092: Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT (2024), 0 descendants of its own

## Indications for use
The Alma Hybrid Laser System, Delivery Devices, Applicators and Accessories are 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). HyLight-CO2 The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared 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. Pixel The Alma Hybrid Pixel CO2 fractional applicator, with wavelength of 10600 nm is indicated for: The ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery in the performance of skin resurfacing. ProScan The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for: » Laser skin resurfacing (ablation and/or vaporization) of soft tissue. The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for: » Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue The Alma Hybrid ProScan CO2 &1570nm fractional applicator, 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/K203441
Methodology: https://510kreport.com/methodology