K223919
- 510(k) number
- K223919
- Device name
- B.Light Clear Evo and B.Light Restore Evo
- Applicant
- Bemer Int AG LI
- Product code
- OHS — Light Based Over The Counter Wrinkle Reduction
- Decision date
- 2023-09-23
- Date received
- 2022-12-29
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K223919.pdf
Official FDA record: K223919
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.