DeviceClearance

Q Switched Nd:YAG Laser machine (QLQW-01)— 510(k) K261841

Substantially Equivalent

Beijing Nubway S&T Co., Ltd.

FDA 510(k) clearance K261841 for Q Switched Nd:YAG Laser machine (QLQW-01), Substantially Equivalent on 2026-08-11. Applicant: Beijing Nubway S&T Co., Ltd.. Device class: 2.

Summary

Beijing Nubway S&T filed a Q Switched Nd:YAG Laser machine, model QLQW-01, under product code GEX, powered laser surgical instruments.

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).

Nubway filed from Beijing, China. Review took 69 calendar days (June 3 to August 11, 2026) and ended in a substantially equivalent decision.

Clearance details

Applicant
Beijing Nubway 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
Beijing, 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.