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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

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Company

Sanhe Lefis Electronics Co., Ltd.
China (CN)

Product code

GEX
21 CFR 878.4810

Predicate devices

3
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K250998
Device name
CO2 Laser Therapy System (Model: LFS-D9U)
Company
Sanhe Lefis Electronics Co., Ltd.
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

3

K250998 references 3 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K250998 as a predicate