Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K191484 |
Device Name |
Renuvion/J-Plasma Precise Handpiece |
Applicant |
Apyx Medical Corporation(formerly Bovie Medical Corporation) |
5115 Ulmerton Road |
Clearwater,
FL
33760
|
|
Applicant Contact |
Topaz Kirlew |
Correspondent |
Apyx Medical Corporation(formerly Bovie Medical Corporation) |
5115 Ulmerton Road |
Clearwater,
FL
33760
|
|
Correspondent Contact |
Topaz Kirlew |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 06/04/2019 |
Decision Date | 07/30/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|