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Dermatological Carbon Dioxide Laser Systems

Zhuolu Jontelaser Manufacturing Technology Co., Ltd.

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

Product code GEX· 21 CFR 878.4810

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Company

Zhuolu Jontelaser Manufacturing Technology Co., Ltd.
China (CN)

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
K202250
Device name
Dermatological Carbon Dioxide Laser Systems
Company
Zhuolu Jontelaser Manufacturing Technology Co., Ltd.
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2020-08-10
Decision date
2020-11-25
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 Dermatological Carbon Dioxide Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.

Intended Use

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

Device Description

The Dermatological Carbon Dioxide Laser Systems is a gas laser with a wavelength of 10600 nm. The laser energy density is high and the divergence angle is very small. The focused light beam is used for vaporization and coagulation of human tissue.

Summary parsed at:2026-06-01 05:48:29 UTC

Predicate devices

1

K202250 references 1 predicate/reference device

Cited as predicate

1

1 submission cite K202250 as a predicate