Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K211652 |
Device Name |
Renuvion Dermal Handpiece, Renuvion Dermal System |
Applicant |
Apyx Medical Corporation (formerly Bovie Medical Corporation |
5115 Ulmerton Road |
Clearwater,
FL
33760 -4004
|
|
Applicant Contact |
Topaz Kirlew |
Correspondent |
Apyx Medical Corporation (formerly Bovie Medical Corporation |
5115 Ulmerton Road |
Clearwater,
FL
33760 -4004
|
|
Correspondent Contact |
Priscilla Herpai |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 05/28/2021 |
Decision Date | 05/25/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT03286283 NCT04185909
|
Reviewed by Third Party |
No
|
Combination Product |
No
|