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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 / April 2026 / K260647

510(k) cleared

SPECCHIO

El.En S.P.A. · Apr 2, 2026 · K260647

FDA cleared the SPECCHIO from El.En S.P.A. on Apr 2, 2026 under K260647, a special 510(k). The device falls under product code PBX, Massager, Vacuum, Radio Frequency Induced Heat, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Feb 27, 2026. The decision came 34 days later, inside the 90 FDA-day goal for a 510(k).

El.En S.P.A. has 8 other decisions in the tracker over the last 12 months: K253808 (AIR Recon DL), K253667 (Accoat Guide Wire), K254130 (C.A. Medical Interbody Fusion System), K253317 (Cytrans Elashield).

Questions & Answers

What did FDA clear under K260647?

K260647 is the FDA 510(k) for SPECCHIO, submitted by El.En S.P.A.. FDA's decision date was Apr 2, 2026, under product code PBX (Massager, Vacuum, Radio Frequency Induced Heat).

Who makes the SPECCHIO?

El.En S.P.A., based in Calenzano, is the applicant of record for K260647.

How long did the K260647 review take?

FDA received the submission on Feb 27, 2026 and issued its decision on Apr 2, 2026, 34 days later.

← All decisions in April 2026