K251077
- 510(k) number
- K251077
- Device name
- JOULE 1064nm System and Accessories
- Applicant
- Sciton, Inc CA · US
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-12-19
- Date received
- 2025-04-08
- 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: K251077.pdf
Official FDA record: K251077
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.