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THE TAPE

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 / January 2026 / K252753

510(k) cleared

Vydence Family of Lasers

Vydence Medical Industria E Commercio Ltda · Jan 24, 2026 · K252753

FDA cleared the Vydence Family of Lasers from Vydence Medical Industria E Commercio Ltda on Jan 24, 2026 under K252753, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, 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 Aug 29, 2025. The decision came 148 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 Vydence Medical Industria E Commercio Ltda in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252753?

K252753 is the FDA 510(k) for Vydence Family of Lasers, submitted by Vydence Medical Industria E Commercio Ltda. FDA's decision date was Jan 24, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Vydence Family of Lasers?

Vydence Medical Industria E Commercio Ltda, based in Sal Carlos, is the applicant of record for K252753.

How long did the K252753 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Jan 24, 2026, 148 days later.

← All decisions in January 2026