The following data is part of a premarket notification filed by Bovie Medical Corporation Dba Apyx Medical Corporation with the FDA for Apyx Helium Plasma Generator (apyx-200h/p, Apyx-js3/rs3).
| Device ID | K192867 |
| 510k Number | K192867 |
| Device Name: | Apyx Helium Plasma Generator (APYX-200H/P, APYX-JS3/RS3) |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| Applicant | Bovie Medical Corporation Dba Apyx Medical Corporation 5115 Ulmerton Road Clearwater, FL 33760 -4004 |
| Contact | Topaz Kirlew |
| Correspondent | Dave Yungvirt THIRD PARTY REVIEW GROUP, LLC 25 Independence Blvd Warren, NJ 07059 |
| Product Code | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-10-07 |
| Decision Date | 2019-10-31 |
| Summary: | summary |