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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 / June 2026 / K251684

510(k) cleared

Alma TED+ System

Alma Lasers, Inc. · Jun 5, 2026 · K251684

FDA cleared the Alma TED+ System from Alma Lasers, Inc. on Jun 5, 2026 under K251684, a traditional 510(k). The device falls under product code OAP, Laser, Comb, Hair, regulated at 21 CFR 890.5500 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jun 2, 2025. The decision came 368 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 Alma Lasers, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K251684?

K251684 is the FDA 510(k) for Alma TED+ System, submitted by Alma Lasers, Inc.. FDA's decision date was Jun 5, 2026, under product code OAP (Laser, Comb, Hair).

Who makes the Alma TED+ System?

Alma Lasers, Inc., based in Buffalo Grove, IL, is the applicant of record for K251684.

How long did the K251684 review take?

FDA received the submission on Jun 2, 2025 and issued its decision on Jun 5, 2026, 368 days later.

← All decisions in June 2026