Renuvion APR Handpiece

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 Apr Handpiece.

Pre-market Notification Details

Device IDK220970
510k NumberK220970
Device Name:Renuvion APR Handpiece
ClassificationElectrosurgical, Cutting & Coagulation & Accessories
Applicant Apyx Medical Corporation(formerly Bovie Medical Corporation) 5115 Ulmerton Road Clearwater,  FL  33760 -4004
ContactPriscilla Herpai
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 Received2022-04-04
Decision Date2022-07-15

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