Cortex Laser System

Cynosure, Inc. Dba Ellman

Country / region:United States (US)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

3

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K150587
Device name
Cortex Laser System
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-03-09
Decision date
2015-07-21
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cutting
Primary application
Surgical cutting
Classification source
AI classified

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).

Intended 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).

Device Description

The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. The Er:YAG handpiece attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.

Summary parsed at:2026-06-01 06:10:58 UTC

Predicate devices

3

K150587 references 3 predicate/reference devices

Cited as predicate

1

1 submission cite K150587 as a predicate