K234004
- 510(k) number
- K234004
- Device name
- Medical diode laser systems (CHARISMA, REGAL)
- Applicant
- Reveal Lasers , Ltd. IL
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-02-20
- Date received
- 2023-12-19
- 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: K234004.pdf
Official FDA record: K234004
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.