Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.CO2 Laser Therapy System
Shanghai Apolo Medical Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
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—
—
Not ingested
EdgeOne CO2 Laser
K201109 references 2 predicate/reference devices
Cited as predicate
3CO2 Laser System
CO2 Laser Machine (Lume)
CO2 Laser Therapy System (Model: LFS-D9U)
3 submissions cite K201109 as a predicate