Manufacturer
Sanhe Lefis Electronics Co., Ltd.CO2 Laser Therapy System (Model: LFS-D9U)
Sanhe Lefis Electronics Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250998
- Device name
- CO2 Laser Therapy System (Model: LFS-D9U)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-04-01
- Decision date
- 2025-12-19
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Skin resurfacingSurgical cutting
- Primary application
- Skin resurfacing
- Classification source
- AI classified
Indications for Use
The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.
Intended Use
The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing.
Device Description
CO2 Laser Therapy System (Model: LFS-D9U) uses infrared beam with a wavelength of 10.6 µm for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing. The device comprises a main unit, therapy head, light guide system, and footswitch.
Summary parsed at:2026-06-01 05:22:44 UTC
Predicate devices
3EdgeOne CO2 Laser
CO2 Laser System
CO2 Laser Therapy System
K250998 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K250998 as a predicate