K254197
- 510(k) number
- K254197
- Device name
- Picasso Pro Diode Laser (002-00460)
- Applicant
- CAO Group, Inc. UT · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2026-03-11
- Date received
- 2025-12-23
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.7 MB · U.S. public domain
Also available from FDA: K254197.pdf
Official FDA record: K254197
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.