The following data is part of a premarket notification filed by Apyx Medical Corporation (formerly Bovie Medical Corporation with the FDA for Renuvion Dermal Handpiece, Renuvion Dermal System.
| Device ID | K211652 |
| 510k Number | K211652 |
| Device Name: | Renuvion Dermal Handpiece, Renuvion Dermal System |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Apyx Medical Corporation (formerly Bovie Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 -4004 |
| Contact | Topaz Kirlew |
| Correspondent | Priscilla Herpai Apyx Medical Corporation (formerly Bovie Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 -4004 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-28 |
| Decision Date | 2022-05-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607151050214 | K211652 | 000 |
| 00607151050184 | K211652 | 000 |