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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 / May 2026 / K261325

510(k) cleared

Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)

Shenzhen Ulike Smart Electronics Co., Ltd. · May 21, 2026 · K261325

FDA cleared the Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU) from Shenzhen Ulike Smart Electronics Co., Ltd. on May 21, 2026 under K261325, 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 Apr 22, 2026. The decision came 29 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: K260742 (Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)), K260511 (Ulike Reglow Light Therapy Device (UM10)).

Questions & Answers

What did FDA clear under K261325?

K261325 is the FDA 510(k) for Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU), submitted by Shenzhen Ulike Smart Electronics Co., Ltd.. FDA's decision date was May 21, 2026, under product code OHT (Light Based Over-The-Counter Hair Removal).

Who makes the Ice Cooling IPL Hair Removal Device (UI06S PR, UI06S PN, UI06S WH, UI06S PRU, UI06S PNU, UI06S WHU)?

Shenzhen Ulike Smart Electronics Co., Ltd., based in Shenzhen, is the applicant of record for K261325.

How long did the K261325 review take?

FDA received the submission on Apr 22, 2026 and issued its decision on May 21, 2026, 29 days later.

← All decisions in May 2026

Sources