Apyx Plasma/RF Handpiece
K-Number: K191542 · 2019-10-11
Decision Date2019-10-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Apyx Plasma/RF Handpiece is a medical device manufactured by Bovie Medical Corporation Dba Apyx Medical Corporation. It received FDA 510(k) clearance on 2019-10-11 under approval number K191542. 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 Apyx Plasma/RF Handpiece?
Apyx Plasma/RF Handpiece is a medical device that received FDA 510(k) clearance on 2019-10-11. It is manufactured by Bovie Medical Corporation Dba Apyx Medical Corporation. The 510(k) number is K191542.
When was Apyx Plasma/RF Handpiece approved by the FDA?
Apyx Plasma/RF Handpiece received FDA 510(k) clearance on 2019-10-11, under approval number K191542.
What company makes Apyx Plasma/RF Handpiece?
Apyx Plasma/RF Handpiece is manufactured by Bovie Medical Corporation Dba Apyx Medical Corporation.
What is the FDA product code for Apyx Plasma/RF Handpiece?
The FDA product code for Apyx Plasma/RF 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.