The following data is part of a premarket notification filed by Bovie Medical Corporation with the FDA for Renuvion/j-plasma Precise Handpiece, Renuvion/j-plasma Precise Open Handpieces, Renuvion/j-plasma Precise Open Handpieces.
| Device ID | K183610 |
| 510k Number | K183610 |
| Device Name: | Renuvion/J-Plasma Precise Handpiece, Renuvion/J-Plasma Precise Open Handpieces, Renuvion/J-Plasma Precise Open Handpieces |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Bovie Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 |
| Contact | Rubiela Maldonado |
| Correspondent | Topaz Kirlew 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 | 2018-12-26 |
| Decision Date | 2019-03-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00607151012441 | K183610 | 000 |
| 00607151050061 | K183610 | 000 |
| 00607151050054 | K183610 | 000 |
| 00607151050047 | K183610 | 000 |
| 00607151050030 | K183610 | 000 |
| 00607151050023 | K183610 | 000 |
| 00607151050016 | K183610 | 000 |
| 00607151050009 | K183610 | 000 |