Manufacturer
Beijing Adss Development Co., Ltd.CO2 Laser Therapy Machine
Beijing Adss Development 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
- K161925
- Device name
- CO2 Laser Therapy Machine
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-07-13
- Decision date
- 2016-10-05
- 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 Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Intended Use
The CO2 Laser Therapy Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Device Description
The CO2 Laser Therapy Machine is a carbon dioxide laser used in medical and aesthetic industry for treatment of such skin conditions as fine and coarse wrinkles, scars of various origin, uneven pigmentation and dilated pores. Due to the CO2 laser's high absorption of water, its high-energy beam of laser light interacts with the skin's surface causing the upper layer to peel off and use photothermolysis to stimulate deep cell regeneration and then achieve the target of skin improvement. The proposed device is mainly used for human tissue vaporization, carbonization, coagulation and exposure to achieve the purpose of treatment. The CO2 Laser Therapy Machine includes three models in this submission, FG 900, FG 900-B and FG 900-C, all three models have same principle, software, operation etc., only differences are appearance. The proposed device includes the following components: Surgery tip to deliver the laser to area to be treated, articulated arm for holding of Surgery tip, touchscreen for user interface and controlling of the system, emergency stop switch, key switch to start the system, goggles for patient and doctor to protect their eyes, and foot switch to activate the laser emission.
Summary parsed at:2026-06-01 06:06:45 UTC
Predicate devices
1—
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Not ingested
K161925 references 1 predicate/reference device
Cited as predicate
6CO2 Laser Therapy System
ND:YAG Laser
CO2 Laser System
CO2 Laser Therapy Systems (SHE-LSP003-1)
CO2 Laser System (CO2 Laser SST-L23)
CO2 Laser Therapy System (K106)
6 submissions cite K161925 as a predicate
