CO2 Laser Therapy System

Shanghai Apolo Medical Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K201109
Device name
CO2 Laser Therapy System
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-04-27
Decision date
2020-07-15
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The CO2 Laser Therapy System is used for body soft tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology.

Intended Use

The CO2 Laser Therapy System is used for body soft tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology.

Device Description

The CO2 Laser Therapy Systems generate a 10,600nm wavelength, which is absorbed by water in the tissue. The laser energy heats up the water until it reaches a boiling point causing the evaporation of the affected tissue. Some heat is absorbed by tissue adjacent to the ablated target area, causing tissue coagulation which induces hemostasis (the cessation of bleeding) as well as thermal stimulation of deep skin layers, which induces fibroblast stimulation and neocollagenesis (the formation of new collagen).

Summary parsed at:2026-06-01 05:48:08 UTC

Predicate devices

2

K201109 references 2 predicate/reference devices

Cited as predicate

3

3 submissions cite K201109 as a predicate