DeviceClearance

LED Therapy Device (QLXY-01)— 510(k) K261673

Substantially Equivalent

Beijing Nubway S&T Co., Ltd.

FDA 510(k) clearance K261673 for LED Therapy Device (QLXY-01), Substantially Equivalent on 2026-09-17. Applicant: Beijing Nubway S&T Co., Ltd.. Device class: 2.

Summary

LED Therapy Device (QLXY-01) is from Beijing Nubway S&T Co., Ltd., filed under product code GEX (Powered Laser Surgical Instrument). The record gives the model number and nothing else about the device.

Class II, 21 CFR 878.4810. General, Plastic Surgery is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.

Nubway filed from Beijing, China. The decision came 119 calendar days after receipt (May 21 to September 17, 2026).

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.