K233007
- 510(k) number
- K233007
- Device name
- Picosecond Nd:YAG Laser System; PICO LEGEND
- Applicant
- Ami, Inc. KR
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2024-06-12
- Date received
- 2023-09-22
- 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: K233007.pdf
Official FDA record: K233007
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.