# K241092: Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Oct 10, 2024 after 171 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: 22 generations back to K910422 (1992). 336 ancestors in all.
No later device cites it as a predicate yet.
0 of 337 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.
- K222221: Deka Helix, El.En Electronic Engineering Spa (2023) Summary page 6.
- K182669: Youlaser CO2, Quanta System Spa (2018) Summary page 6.

## Indications for use
The Youlaser PRIME family laser devices (Youlaser PRIME, Youlaser PRIME CO2, Youlaser PRIME MT) 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). Surgical Handpieces Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with surgical handpieces 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. OptiScan PRIME Scanner Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with OptiScan PRIME scanner are indicated for: *Laser skin resurfacing (ablation and/or vaporization) of soft tissue Youlaser PRIME and Youlaser PRIME MT with wavelength of 1550nm used in combination with OptiScan PRIME scanner, are indicated for: » Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue Youlaser PRIME MT with wavelengths of 10600nm & 1550nm used in combination with OptiScan PRIME is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.

Source page: https://510kreport.com/device/K241092
Methodology: https://510kreport.com/methodology