# K182669: Youlaser CO2

- Pathway: 510(k) (Special)
- Applicant: Quanta System Spa
- Decided: Oct 17, 2018 after 22 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: 15 generations back to K910422 (1992). 157 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 159 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123573: Youlaser CO2 Laser, Quanta System Spa (2013) Summary page 4.

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

## Indications for use
When used in traditional, non-fractionated mode for: Incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing.

Source page: https://510kreport.com/device/K182669
Methodology: https://510kreport.com/methodology