Diode Laser Hair Removal Machine (QDTM-03)— 510(k) K261692
Substantially EquivalentBeijing Nubway S&T Co., Ltd.
FDA 510(k) clearance K261692 for Diode Laser Hair Removal Machine (QDTM-03), Substantially Equivalent on 2026-10-07. Applicant: Beijing Nubway S&T Co., Ltd.. Device class: 2.
Summary
Beijing Nubway S&T's Diode Laser Hair Removal Machine, model QDTM-03, is filed under GEX, powered laser surgical instruments, not the over-the-counter hair removal code (OHT). The record doesn't give wavelength or power specifications.
Class II, 21 CFR 878.4810. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
The applicant is based in Beijing, China. Review took 138 days (May 22 to October 7, 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.