CO2 Laser System (CO2 Laser SST-L23)

Zhuozhou Summer Star Technologies Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

View Summary PDF

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K250183
Device name
CO2 Laser System (CO2 Laser SST-L23)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2025-01-22
Decision date
2025-04-24
Submission type
Traditional
Technology type
CO2(AI inferred)
Clinical applications
Surgical cuttingSkin resurfacing
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Intended Use

CO2 Laser System is used for human tissue vaporization, coagulation in dermatoloty and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Device Description

CO2 Laser System is a laser beam generated by electrically excited carbon dioxide gas molecules, which has a very small divergence angle and high energy density. After focusing, it can reach a power of several kilowatts per square centimeter for vaporization. The unfocused original light beam irradiates the lesion tissue, which can cause coagulation of biological tissue. The CO2 laser penetrates the tissue deeper, and after irradiation, it can heat and treat the deep tissue.

Summary parsed at:2026-06-01 05:22:13 UTC

Predicate devices

2

K250183 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K250183 as a predicate