# K111592: Youlaser CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Quanta System Spa
- Decided: Aug 25, 2011 after 79 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: 1 generation back to K072159 (2007). 1 ancestor in all.
3 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072159: Smart CO2 (Smartxide, Smart US20D) with Dot Scanner, El.En Electronic Engineering Spa (2007) Summary page 1.

## Most influential descendants
- K133915: Galaxy CO2 Laser System (2014), 2 descendants of its own
- K150587: Cortex Laser System (2015), 1 descendant of its own
- K161356: Matrix LS-40 CO2 Laser System (2016), 0 descendants of its own

## Indications for use
YOULASER C02 Laser 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), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER C02 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application: Dyschromia, Atrophic + Acne scars, Hypertrophic scars The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area. The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device

Source page: https://510kreport.com/device/K111592
Methodology: https://510kreport.com/methodology