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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 / March 2026 / K253965

510(k) cleared

CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)

Wuhan PHOMED Technology Company , Ltd. · Mar 19, 2026 · K253965

FDA cleared the CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.) from Wuhan PHOMED Technology Company , Ltd. on Mar 19, 2026 under K253965, a traditional 510(k). The device falls under product code ILY, Lamp, Infrared, Therapeutic Heating, regulated at 21 CFR 890.5500 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Dec 11, 2025. The decision came 98 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Wuhan PHOMED Technology Company , Ltd. has one other decision in the tracker over the last 12 months: K262346 (CureLight Medical Diode Laser Systems (S3-BF45);CureLight Medical Diode Laser Systems (S2-B30);CureLight Medical Diode Laser Systems (S3-BF30);CureLight Medical Diode Laser Systems (S2-F15);CureLight Medical Diode Laser Systems (S2-H7.5)).

Questions & Answers

What did FDA clear under K253965?

K253965 is the FDA 510(k) for CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.), submitted by Wuhan PHOMED Technology Company , Ltd.. FDA's decision date was Mar 19, 2026, under product code ILY (Lamp, Infrared, Therapeutic Heating).

Who makes the CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)?

Wuhan PHOMED Technology Company , Ltd., based in Wuhan, is the applicant of record for K253965.

How long did the K253965 review take?

FDA received the submission on Dec 11, 2025 and issued its decision on Mar 19, 2026, 98 days later.

← All decisions in March 2026

Sources