CO2 Laser Machine (Monica-I,Monica-II)

Nanjing Bestview Laser S&T Co., Ltd.

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

Product code GEX· 21 CFR 878.4810

Company

Nanjing Bestview Laser S&T Co., Ltd.

China (CN)

Product code

GEX

21 CFR 878.4810

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Device details

FDA 510(k) registration fields

K number: K260974
Device name: CO2 Laser Machine (Monica-I,Monica-II)
Company: Nanjing Bestview Laser S&T Co., Ltd.
Country / region: China(CN)
Product code: GEX
Device class: Class 2
Regulation number: 21 CFR 878.4810
Date received: 2026-03-24
Decision date: 2026-05-07
Submission type: Traditional
Technology type: CO2(unclassified)
Clinical applications: Skin resurfacingSurgical cutting
Primary application: Skin resurfacing
Classification source: AI classified

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