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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 / July 2026 / K261473

510(k) cleared

Chromix

Termosalud S.L. · Jul 1, 2026 · K261473

FDA cleared the Chromix from Termosalud S.L. on Jul 1, 2026 under K261473, a traditional 510(k). The device falls under product code OHS, Light Based Over The Counter Wrinkle Reduction, 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 May 4, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

Termosalud S.L. has one other decision in the tracker over the last 12 months: K253636 (Zionic Pro Max (EMS)).

Questions & Answers

What did FDA clear under K261473?

K261473 is the FDA 510(k) for Chromix, submitted by Termosalud S.L.. FDA's decision date was Jul 1, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the Chromix?

Termosalud S.L., based in Gijon, is the applicant of record for K261473.

How long did the K261473 review take?

FDA received the submission on May 4, 2026 and issued its decision on Jul 1, 2026, 58 days later.

← All decisions in July 2026

Sources