K243630
- 510(k) number
- K243630
- Device name
- Medical Laser System Incanto / Evoline Platinum /Evoline
- Applicant
- Solar LS Cjsc BY
- Product code
- GEX — Powered Laser Surgical Instrument
- Decision date
- 2025-03-21
- Date received
- 2024-11-25
- 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: K243630.pdf
Official FDA record: K243630
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.