Renuvion Dermal Handpiece, Renuvion Dermal System

Electrosurgical, Cutting & Coagulation & Accessories

Apyx Medical Corporation (formerly Bovie Medical Corporation

The following data is part of a premarket notification filed by Apyx Medical Corporation (formerly Bovie Medical Corporation with the FDA for Renuvion Dermal Handpiece, Renuvion Dermal System.

Pre-market Notification Details

Device IDK211652
510k NumberK211652
Device Name:Renuvion Dermal Handpiece, Renuvion Dermal System
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Apyx Medical Corporation (formerly Bovie Medical Corporation 5115 Ulmerton Road Clearwater,  FL  33760 -4004
ContactTopaz Kirlew
CorrespondentPriscilla Herpai
Apyx Medical Corporation (formerly Bovie Medical Corporation 5115 Ulmerton Road Clearwater,  FL  33760 -4004
Product CodeGEI  
CFR Regulation Number878.4400 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-28
Decision Date2022-05-25

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