Renuvion Dermal Handpiece, Renuvion Dermal System— 510(k) K211652
Substantially EquivalentApyx Medical Corporation (Formerly Bovie Medical Corporation
FDA 510(k) clearance K211652 for Renuvion Dermal Handpiece, Renuvion Dermal System, Substantially Equivalent on 2022-05-25. Applicant: Apyx Medical Corporation (Formerly Bovie Medical Corporation.
Clearance details
- Applicant
- Apyx Medical Corporation (Formerly Bovie Medical Corporation
- Product code
- Code GEI
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Clearwater, FL, US
Adverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.