The following data is part of a premarket notification filed by Apyx Medical Corporation(formerly Bovie Medical Corporation) with the FDA for Renuvion Apr Handpiece.
| Device ID | K220970 |
| 510k Number | K220970 |
| Device Name: | Renuvion APR Handpiece |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Apyx Medical Corporation(formerly Bovie Medical Corporation) 5115 Ulmerton Road Clearwater, FL 33760 -4004 |
| Contact | Priscilla Herpai |
| 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 | 2022-04-04 |
| Decision Date | 2022-07-15 |