Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K223262 |
Device Name |
Renuvion® APR Handpiece |
Applicant |
Apyx Medical Corporation |
(formerly Bovie Medical Corporation) |
5115 Ulmerton Road |
Clearwater,
FL
33760 -4004
|
|
Applicant Contact |
Mark D. Evans |
Correspondent |
Apyx Medical Corporation |
(formerly Bovie Medical Corporation) |
5115 Ulmerton Road |
Clearwater,
FL
33760 -4004
|
|
Correspondent Contact |
Mark D. Evans |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 10/24/2022 |
Decision Date | 02/23/2023 |
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
|