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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 / September 2026 / K261975

510(k) cleared

Braun Aura 7 (6041)

CyDen Limited · Sep 30, 2026 · K261975

FDA cleared the Braun Aura 7 (6041) from CyDen Limited on Sep 30, 2026 under K261975, a special 510(k). The device falls under product code OHT, Light Based Over-The-Counter Hair Removal, 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 Jun 12, 2026. The decision came 110 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

CyDen Limited has one other decision in the tracker over the last 12 months: K261977 (Braun Aura 9 (6042)).

Questions & Answers

What did FDA clear under K261975?

K261975 is the FDA 510(k) for Braun Aura 7 (6041), submitted by CyDen Limited. FDA's decision date was Sep 30, 2026, under product code OHT (Light Based Over-The-Counter Hair Removal).

Who makes the Braun Aura 7 (6041)?

CyDen Limited, based in Swansea, is the applicant of record for K261975.

How long did the K261975 review take?

FDA received the submission on Jun 12, 2026 and issued its decision on Sep 30, 2026, 110 days later.

← All decisions in September 2026

Sources