K251801
- 510(k) number
- K251801
- Device name
- Diode laser device (BM091)
- Applicant
- Hebei Newangie Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-08-08
- Date received
- 2025-06-12
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K251801.pdf
Official FDA record: K251801
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.