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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

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: K261217 (AnyPlus II Spinal Fixation System), K254302 (ECG Analysis Software (AiTiALVSD)), K260250 (QCA 10 Electrocardiograph (QCARD-10); QCA 10W Electrocardiograph (QCARD-10W)), K243223 (Multiple therapy aesthetic treatment device (BHS 202 UNYQUE)).

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