# K150587: Cortex Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Cynosure, Inc. Dba Ellman
- Decided: Jul 21, 2015 after 134 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: 19 generations back to K943450 (1995). 390 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 392 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110897: Cortex CO2 / ER:Yag Laser System, Sandstone Medical Technologies, LLC (2011) Summary page 4.
- K133895: Deka Smartxide Laser System, El.En S.P.A. (2014) Summary page 4.
- K133915: Galaxy CO2 Laser System, Beijing Toplaser Technology Co., Ltd. (2014) Summary page 4.

## Most influential descendants
- K161356: Matrix LS-40 CO2 Laser System (2016), 0 descendants of its own

## Indications for use
The CO2 laser 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, orthopedics, general and thoracic 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. The Er:YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, vaporization, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).

Source page: https://510kreport.com/device/K150587
Methodology: https://510kreport.com/methodology