Diode laser hair removal machine (QDTM-04)— 510(k) K261693
Substantially EquivalentBeijing Nubway S&T Co., Ltd.
FDA 510(k) clearance K261693 for Diode laser hair removal machine (QDTM-04), Substantially Equivalent on 2026-07-17. Applicant: Beijing Nubway S&T Co., Ltd.. Device class: 2.
Summary
Beijing Nubway S&T's Diode laser hair removal machine (QDTM-04) is filed under GEX, powered laser surgical instruments. The record gives the model as QDTM-04 but no wavelength or power specs.
Class II, 21 CFR 878.4810. General and Plastic Surgery is both the classification panel and the review panel. It was a Traditional 510(k).
Beijing Nubway filed from Beijing, China. Review took 56 calendar days (May 22 to July 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
Recent devices under product code GEX
view allMore clearances from Beijing Nubway S&T Co., Ltd.
view allAdverse 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.