Renuvion Dermal Handpiece, Renuvion Dermal System
K-Number: K211652 · 2022-05-25
Decision Date2022-05-25
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Renuvion Dermal Handpiece, Renuvion Dermal System is a medical device manufactured by Apyx Medical Corporation (Formerly Bovie Medical Corporation. It received FDA 510(k) clearance on 2022-05-25 under approval number K211652. 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 Dermal Handpiece, Renuvion Dermal System?
Renuvion Dermal Handpiece, Renuvion Dermal System is a medical device that received FDA 510(k) clearance on 2022-05-25. It is manufactured by Apyx Medical Corporation (Formerly Bovie Medical Corporation. The 510(k) number is K211652.
When was Renuvion Dermal Handpiece, Renuvion Dermal System approved by the FDA?
Renuvion Dermal Handpiece, Renuvion Dermal System received FDA 510(k) clearance on 2022-05-25, under approval number K211652.
What company makes Renuvion Dermal Handpiece, Renuvion Dermal System?
Renuvion Dermal Handpiece, Renuvion Dermal System is manufactured by Apyx Medical Corporation (Formerly Bovie Medical Corporation.
What is the FDA product code for Renuvion Dermal Handpiece, Renuvion Dermal System?
The FDA product code for Renuvion Dermal Handpiece, Renuvion Dermal System 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.