AYON Body Contouring System (AYON SYSTEM)
K-Number: K253396 · 2026-05-08
ApplicantApyx Medical Corporation
Decision Date2026-05-08
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
AYON Body Contouring System (AYON SYSTEM) is a medical device manufactured by Apyx Medical Corporation. It received FDA 510(k) clearance on 2026-05-08 under approval number K253396. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the AYON Body Contouring System (AYON SYSTEM)?
AYON Body Contouring System (AYON SYSTEM) is a medical device that received FDA 510(k) clearance on 2026-05-08. It is manufactured by Apyx Medical Corporation. The 510(k) number is K253396.
When was AYON Body Contouring System (AYON SYSTEM) approved by the FDA?
AYON Body Contouring System (AYON SYSTEM) received FDA 510(k) clearance on 2026-05-08, under approval number K253396.
What company makes AYON Body Contouring System (AYON SYSTEM)?
AYON Body Contouring System (AYON SYSTEM) is manufactured by Apyx Medical Corporation.
What is the FDA product code for AYON Body Contouring System (AYON SYSTEM)?
The FDA product code for AYON Body Contouring System (AYON SYSTEM) is QPB.
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.