DeviceClearance

Q-Switched Nd: YAG Laser System (Glamor Q)— 510(k) K260153

Substantially Equivalent

Nanjing Bestview Laser S&T Co., Ltd.

FDA 510(k) clearance K260153 for Q-Switched Nd: YAG Laser System (Glamor Q), Substantially Equivalent on 2026-04-20. Applicant: Nanjing Bestview Laser S&T Co., Ltd.. Device class: 2.

Summary

Nanjing Bestview Laser's Q-Switched Nd: YAG Laser System (Glamor Q) is filed under product code GEX (Powered Laser Surgical Instrument).

Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It came in as a Traditional 510(k).

Nanjing Bestview Laser filed from China, with the city listed as "Nanjing Economic & Technological Develop". The record shows 90 calendar days from receipt to decision (January 20 to April 20, 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 Economic & Technological Develop, 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.