# K123573: Youlaser CO2 Laser

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Apr 15, 2013 after 146 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: 14 generations back to K910422 (1992). 156 ancestors in all.
19 later devices descend from it; 4 cite it directly.
0 of 176 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080496: Mosaic ECO2 Laser System, Lutronic Corporation (2008) Summary page 1.
- K091115: ECO2 Laser System, Lutronic Corporation (2009) Summary page 1.
- K063001: Slim Evolution Family of CO2 Lasers and Delivery Device Accessories, Lasering S.R.L. (2007) Summary page 1.
- K110984: Slim E30 II CO2 Laser, Lasering S.R.L. (2011) Summary page 1.
- K072159: Smart CO2 (Smartxide, Smart US20D) with Dot Scanner, El.En Electronic Engineering Spa (2007) Summary page 1.

## Most influential descendants
- K160312: Fraxis Duo (2016), 14 descendants of its own
- K170325: Secret RF (2017), 10 descendants of its own
- K210084: Silkro (2022), 3 descendants of its own
- K180654: PINXEL-RF system (2018), 3 descendants of its own
- K172096: Fraxis (2017), 2 descendants of its own

## Indications for use
YOULASER C02 laser when used in traditional, non fractionated mode is indicated 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. YOULASER C02 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing. YOULASER 002 laser when used in traditional, non fractionated mode is indicated 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. YOULASER 002 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacihg.

Source page: https://510kreport.com/device/K123573
Methodology: https://510kreport.com/methodology