K253951
- 510(k) number
- K253951
- Device name
- Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
- Applicant
- Guangzhou Potent Medical Equipment Joint-Stock Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-03-06
- Date received
- 2025-12-10
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K253951.pdf
Official FDA record: K253951
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.