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CO2 Laser System

Beijing Superlaser Technology Co., Ltd.

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

Product code GEX· 21 CFR 878.4810

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Company

Beijing Superlaser Technology Co., Ltd.
China (CN)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

4
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Device details

FDA 510(k) registration fields

K number
K200042
Device name
CO2 Laser System
Company
Beijing Superlaser Technology Co., Ltd.
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-01-08
Decision date
2020-06-09
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 System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Intended Use

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

Device Description

The device emits CO2 laser at the wavelength of 10.6µm, which is the spectral line in the far infrared range. The device is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Summary parsed at:2026-06-01 05:47:36 UTC

Predicate devices

2

K200042 references 2 predicate/reference devices

Cited as predicate

4

4 submissions cite K200042 as a predicate