Apyx One Console
K-Number: K221830 · 2022-10-11
ApplicantApyx Medical Corporation
Decision Date2022-10-11
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
Apyx One Console is a medical device manufactured by Apyx Medical Corporation. It received FDA 510(k) clearance on 2022-10-11 under approval number K221830. 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 One Console?
Apyx One Console is a medical device that received FDA 510(k) clearance on 2022-10-11. It is manufactured by Apyx Medical Corporation. The 510(k) number is K221830.
When was Apyx One Console approved by the FDA?
Apyx One Console received FDA 510(k) clearance on 2022-10-11, under approval number K221830.
What company makes Apyx One Console?
Apyx One Console is manufactured by Apyx Medical Corporation.
What is the FDA product code for Apyx One Console?
The FDA product code for Apyx One Console 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.