The following data is part of a premarket notification filed by Apyx Medical Corporation with the FDA for Apyx One Console.
| Device ID | K221830 |
| 510k Number | K221830 |
| Device Name: | Apyx One Console |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Apyx Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 -4004 |
| Contact | David Ceretti |
| Correspondent | David Ceretti Apyx 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 | 2022-06-23 |
| Decision Date | 2022-10-11 |