K252319
- 510(k) number
- K252319
- Device name
- Q-Switched Nd: YAG Laser machine (LFS-C13U)
- Applicant
- Sanhe Lefis Electronics Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-10-20
- Date received
- 2025-07-25
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.8 MB · U.S. public domain
Also available from FDA: K252319.pdf
Official FDA record: K252319
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.