CO2 Laser Machine, Model: BW-203B

Zhengzhou Bestview ST Co., Ltd.

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

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

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1

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Device details

FDA 510(k) registration fields

K number
K211735
Device name
CO2 Laser Machine, Model: BW-203B
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2021-06-07
Decision date
2021-10-22
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 Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Intended Use

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

Device Description

The CO2 laser machine has two modes, continuous mode and multi-pulse mode. It utilizes CO2 laser to vaporize and heat tissue. During the treatment, the water in skin tissues absorbs laser energy and then vaporizes. Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through a LCD touch-screen.

Summary parsed at:2026-06-01 05:43:15 UTC

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