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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 / October 2025 / K252155

510(k) cleared

AVAVA Skin Treatment System

AVAVA, Inc. · Oct 20, 2025 · K252155

FDA cleared the AVAVA Skin Treatment System from AVAVA, Inc. on Oct 20, 2025 under K252155, a traditional 510(k). The device falls under product code ONG, Powered Laser Surgical Instrument With MicrobeamFractional Output, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 9, 2025. The decision came 103 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 AVAVA, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252155?

K252155 is the FDA 510(k) for AVAVA Skin Treatment System, submitted by AVAVA, Inc.. FDA's decision date was Oct 20, 2025, under product code ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output).

Who makes the AVAVA Skin Treatment System?

AVAVA, Inc., based in Waltham, MA, is the applicant of record for K252155.

How long did the K252155 review take?

FDA received the submission on Jul 9, 2025 and issued its decision on Oct 20, 2025, 103 days later.

← All decisions in October 2025