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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 / October 2026 / K262285

510(k) cleared

UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)

Shijiazhuang Recovery Star Medical Device Co., Ltd. · Oct 5, 2026 · K262285

FDA cleared the UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35) from Shijiazhuang Recovery Star Medical Device Co., Ltd. on Oct 5, 2026 under K262285, a traditional 510(k). The device falls under product code FTC, Light, Ultraviolet, Dermatological, regulated at 21 CFR 878.4630 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jul 6, 2026. The decision came 91 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 Shijiazhuang Recovery Star Medical Device Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262285?

K262285 is the FDA 510(k) for UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35), submitted by Shijiazhuang Recovery Star Medical Device Co., Ltd.. FDA's decision date was Oct 5, 2026, under product code FTC (Light, Ultraviolet, Dermatological).

Who makes the UV Phototherapy Device (KZX-308nm-BL65, KZX-308nm-BL55, KZX-308nm-BL50, KZX-308nm-BL45, KZX-308nm-BL35)?

Shijiazhuang Recovery Star Medical Device Co., Ltd., based in Shijiazhuang, is the applicant of record for K262285.

How long did the K262285 review take?

FDA received the submission on Jul 6, 2026 and issued its decision on Oct 5, 2026, 91 days later.

← All decisions in October 2026