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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 / K260511

510(k) cleared

Ulike Reglow Light Therapy Device (UM10)

Shenzhen Ulike Smart Electronics Co., Ltd. · Mar 16, 2026 · K260511

FDA cleared the Ulike Reglow Light Therapy Device (UM10) from Shenzhen Ulike Smart Electronics Co., Ltd. on Mar 16, 2026 under K260511, a special 510(k). The device falls under product code OHS, Light Based Over The Counter Wrinkle Reduction, 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 Feb 17, 2026. The decision came 27 days later, inside the 90 FDA-day goal for a 510(k).

Shenzhen Ulike Smart Electronics Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K261325 (Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)), K260742 (Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)).

Questions & Answers

What did FDA clear under K260511?

K260511 is the FDA 510(k) for Ulike Reglow Light Therapy Device (UM10), submitted by Shenzhen Ulike Smart Electronics Co., Ltd.. FDA's decision date was Mar 16, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the Ulike Reglow Light Therapy Device (UM10)?

Shenzhen Ulike Smart Electronics Co., Ltd., based in Shenzhen, is the applicant of record for K260511.

How long did the K260511 review take?

FDA received the submission on Feb 17, 2026 and issued its decision on Mar 16, 2026, 27 days later.

← All decisions in March 2026

Sources