J-Plasma Precise FLEX Handpiece
K-Number: K202880 · 2021-01-04
Decision Date2021-01-04
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
J-Plasma Precise FLEX Handpiece is a medical device manufactured by Apyx Medical Corporation (Formerly Bovie Medical Corporation. It received FDA 510(k) clearance on 2021-01-04 under approval number K202880. 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 J-Plasma Precise FLEX Handpiece?
J-Plasma Precise FLEX Handpiece is a medical device that received FDA 510(k) clearance on 2021-01-04. It is manufactured by Apyx Medical Corporation (Formerly Bovie Medical Corporation. The 510(k) number is K202880.
When was J-Plasma Precise FLEX Handpiece approved by the FDA?
J-Plasma Precise FLEX Handpiece received FDA 510(k) clearance on 2021-01-04, under approval number K202880.
What company makes J-Plasma Precise FLEX Handpiece?
J-Plasma Precise FLEX Handpiece is manufactured by Apyx Medical Corporation (Formerly Bovie Medical Corporation.
What is the FDA product code for J-Plasma Precise FLEX Handpiece?
The FDA product code for J-Plasma Precise FLEX 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.