# K133915: Galaxy CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Beijing Toplaser Technology Co., Ltd.
- Decided: Apr 18, 2014 after 116 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). 157 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 160 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091115: ECO2 Laser System, Lutronic Corporation (2009) Summary page 1.
- K111592: Youlaser CO2 Laser System, Quanta System Spa (2011) Summary page 1.
- K110984: Slim E30 II CO2 Laser, Lasering S.R.L. (2011) Summary page 2.

## Most influential descendants
- 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
The C02-28 Galaxy C02 Laser System is intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery, general surgery. Dermatology, Plastic Surgery and General Surgery procedures: Laser skin resurfacing. Treatment of furrows and wrinkles. Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos,telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation. Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. Blepharoplasty. Site preparation for hair transplants. The fractional scanner is for treatment of wrinkles and skin resurfacing.

Source page: https://510kreport.com/device/K133915
Methodology: https://510kreport.com/methodology