K252787
- 510(k) number
- K252787
- Device name
- Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)
- Applicant
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-11-24
- Date received
- 2025-09-02
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K252787.pdf
Official FDA record: K252787
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.