DeviceClearance

CO2 Laser Machine (Monica-I,Monica-II)— 510(k) K260974

Substantially Equivalent

Nanjing Bestview Laser S&T Co., Ltd.

FDA 510(k) clearance K260974 for CO2 Laser Machine (Monica-I,Monica-II), Substantially Equivalent on 2026-05-07. Applicant: Nanjing Bestview Laser S&T Co., Ltd.. Device class: 2.

Summary

Nanjing Bestview Laser S&T's CO2 Laser Machine is listed in two models, Monica-I and Monica-II. It's filed under GEX, powered laser surgical instruments.

Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. The submission was a Traditional 510(k).

Bestview filed from Nanjing, China. Review took 44 calendar days (March 24 to May 7, 2026).

Clearance details

Applicant
Nanjing Bestview Laser S&T Co., Ltd.
Product code
Product code GEX
Device class
Class 2
Regulation
21 CFR 878.4810
Advisory panel
General, Plastic Surgery
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Nanjing, CN
Download summary PDFView on FDA.gov ↗

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Adverse events under product code GEX

product code GEX
Death
33
Injury
3,045
Malfunction
12,903
Other
25
Total
16,006

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.