Renuvion APR Handpiece
K-Number: K220970 · 2022-07-15
Decision Date2022-07-15
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Renuvion APR Handpiece is a medical device manufactured by Apyx Medical Corporation(Formerly Bovie Medical Corporation). It received FDA 510(k) clearance on 2022-07-15 under approval number K220970. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Renuvion APR Handpiece?
Renuvion APR Handpiece is a medical device that received FDA 510(k) clearance on 2022-07-15. It is manufactured by Apyx Medical Corporation(Formerly Bovie Medical Corporation). The 510(k) number is K220970.
When was Renuvion APR Handpiece approved by the FDA?
Renuvion APR Handpiece received FDA 510(k) clearance on 2022-07-15, under approval number K220970.
What company makes Renuvion APR Handpiece?
Renuvion APR Handpiece is manufactured by Apyx Medical Corporation(Formerly Bovie Medical Corporation).
What is the FDA product code for Renuvion APR Handpiece?
The FDA product code for Renuvion APR Handpiece is GEI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.