K253007
- 510(k) number
- K253007
- Device name
- Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
- Applicant
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-11-20
- Date received
- 2025-09-19
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.6 MB · U.S. public domain
Also available from FDA: K253007.pdf
Official FDA record: K253007
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.