K233147
- 510(k) number
- K233147
- Device name
- PiXel8-RF
- Applicant
- Rohrer Aesthetics AL · US
- Product code
- GEI — Electrosurgical, Cutting & Coagulation & Accessories
- Decision date
- 2023-10-25
- Date received
- 2023-09-27
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General, Plastic Surgery
PDFDownload 510(k) SummaryArchived here · 2.5 MB · U.S. public domain
Also available from FDA: K233147.pdf
Official FDA record: K233147
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.