K232656
- 510(k) number
- K232656
- Device name
- BLU TOTALE (Model: ENEOB852)
- Applicant
- Premier North America, Inc. FL · US
- Product code
- OLP — Over-The-Counter Powered Light Based Laser For Acne
- Decision date
- 2023-11-14
- Date received
- 2023-08-31
- 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: K232656.pdf
Official FDA record: K232656
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.