K261674
- 510(k) number
- K261674
- Device name
- Skin Air Cooling System (QALF-01)
- Applicant
- Beijing Nubway S&T Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-07-16
- Date received
- 2026-05-21
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K261674.pdf
Official FDA record: K261674
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.