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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

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.

This is the only decision on file for Apyx Medical Corporation in the last 12 months of the tracker.

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