K252345
- 510(k) number
- K252345
- Device name
- Picosecond Laser Device (PF131-BI)
- Applicant
- Risu Medical Technology Co., Ltd. CN
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-10-23
- Date received
- 2025-07-28
- 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: K252345.pdf
Official FDA record: K252345
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.