Renuvion/J-Plasma Precise Handpiece
K-Number: K191484 · 2019-07-30
Decision Date2019-07-30
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Renuvion/J-Plasma Precise Handpiece is a medical device manufactured by Apyx Medical Corporation(Formerly Bovie Medical Corporation). It received FDA 510(k) clearance on 2019-07-30 under approval number K191484. 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/J-Plasma Precise Handpiece?
Renuvion/J-Plasma Precise Handpiece is a medical device that received FDA 510(k) clearance on 2019-07-30. It is manufactured by Apyx Medical Corporation(Formerly Bovie Medical Corporation). The 510(k) number is K191484.
When was Renuvion/J-Plasma Precise Handpiece approved by the FDA?
Renuvion/J-Plasma Precise Handpiece received FDA 510(k) clearance on 2019-07-30, under approval number K191484.
What company makes Renuvion/J-Plasma Precise Handpiece?
Renuvion/J-Plasma Precise Handpiece is manufactured by Apyx Medical Corporation(Formerly Bovie Medical Corporation).
What is the FDA product code for Renuvion/J-Plasma Precise Handpiece?
The FDA product code for Renuvion/J-Plasma Precise 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.