The following data is part of a premarket notification filed by Bovie Medical Corporation Dba Apyx Medical Corporation with the FDA for Apyx Plasma/rf Handpiece.
| Device ID | K191542 |
| 510k Number | K191542 |
| Device Name: | Apyx Plasma/RF Handpiece |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Bovie Medical Corporation Dba Apyx Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 |
| Contact | Topaz Kirlew |
| Correspondent | Topaz Kirlew Bovie Medical Corporation Dba Apyx Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-06-11 |
| Decision Date | 2019-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607151050160 | K191542 | 000 |
| 00607151050153 | K191542 | 000 |
| 00607151050146 | K191542 | 000 |