The following data is part of a premarket notification filed by Apyx Medical Corporation(formerly Bovie Medical Corporation) with the FDA for Renuvion/j-plasma Precise Handpiece.
| Device ID | K191484 |
| 510k Number | K191484 |
| Device Name: | Renuvion/J-Plasma Precise Handpiece |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Apyx Medical Corporation(formerly Bovie Medical Corporation) 5115 Ulmerton Road Clearwater, FL 33760 |
| Contact | Topaz Kirlew |
| Correspondent | Topaz Kirlew Apyx Medical Corporation(formerly Bovie 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 | 2019-06-04 |
| Decision Date | 2019-07-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607151012434 | K191484 | 000 |
| 00607151050078 | K191484 | 000 |