# K161356: Matrix LS-40 CO2 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
- Decided: Sep 9, 2016 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: 20 generations back to K943450 (1995). 391 ancestors in all.
No later device cites it as a predicate yet.
0 of 392 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150587: Cortex Laser System, Cynosure, Inc. Dba Ellman (2015) Summary page 6.

## Indications for use
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing. The CO2 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 skin resurfacing.

Source page: https://510kreport.com/device/K161356
Methodology: https://510kreport.com/methodology