Skin Air Cooling System (QALF-01)— 510(k) K261674
Substantially EquivalentBeijing Nubway S&T Co., Ltd.
FDA 510(k) clearance K261674 for Skin Air Cooling System (QALF-01), Substantially Equivalent on 2026-07-16. Applicant: Beijing Nubway S&T Co., Ltd.. Device class: 2.
Summary
Beijing Nubway S&T's Skin Air Cooling System (QALF-01) is filed under GEX, powered laser surgical instruments. The device name describes air cooling, which the code name doesn't mention, and the record doesn't explain the fit.
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. The decision came 56 calendar days after FDA received it (May 21 to July 16, 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.