Manufacturer
Beijing Adss Development Co., Ltd.Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
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
- K241670
- Device name
- Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-06-11
- Decision date
- 2024-12-20
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
Fractional CO2 Laser Therapy System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.
Intended Use
Fractional CO2 Laser Therapy System is used for body soft tissue ablation, vaporization, excision and coagulation in dermatology, plastic surgery and general surgery.
Device Description
Fractional CO2 Laser Therapy System consists of a main unit, a light guide arm (including a treatment head), a foot switch, and protective goggles. The fractional CO2 laser penetrates directly into the dermis utilizing the thermal effect of laser, instantly vaporizes the tissue in the lesion area. Parameters such as the laser energy density required for the treatment are set by the user appropriately. The Fractional CO2 Laser Machine has two operational modes, fractional mode and normal mode.
Summary parsed at:2026-06-01 05:28:41 UTC
Predicate devices
1CO2 Laser System
K241670 references 1 predicate/reference device
Cited as predicate
1CO2 Laser Therapy Systems (SHE-LSP003-1)
1 submission cite K241670 as a predicate