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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / May 2026 / K253396

510(k) cleared

AYON Body Contouring System (AYON SYSTEM)

Apyx Medical Corporation · May 8, 2026 · K253396

FDA cleared the AYON Body Contouring System (AYON SYSTEM) from Apyx Medical Corporation on May 8, 2026 under K253396, a traditional 510(k). The device falls under product code QPB, System, Suction, Lipoplasty For Removal, regulated at 21 CFR 878.5040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 30, 2025. The decision came 220 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Apyx Medical Corporation has one other decision in the tracker over the last 12 months: K261710 (AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors).

Questions & Answers

What did FDA clear under K253396?

K253396 is the FDA 510(k) for AYON Body Contouring System (AYON SYSTEM), submitted by Apyx Medical Corporation. FDA's decision date was May 8, 2026, under product code QPB (System, Suction, Lipoplasty For Removal).

Who makes the AYON Body Contouring System (AYON SYSTEM)?

Apyx Medical Corporation, based in Clearwater, FL, is the applicant of record for K253396.

How long did the K253396 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on May 8, 2026, 220 days later.

← All decisions in May 2026

Sources