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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 / K260742

510(k) cleared

Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)

Shenzhen Ulike Smart Electronics Co., Ltd. · May 5, 2026 · K260742

FDA cleared the Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK) from Shenzhen Ulike Smart Electronics Co., Ltd. on May 5, 2026 under K260742, a traditional 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 Mar 6, 2026. The decision came 60 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)), K260511 (Ulike Reglow Light Therapy Device (UM10)).

Questions & Answers

What did FDA clear under K260742?

K260742 is the FDA 510(k) for Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK), submitted by Shenzhen Ulike Smart Electronics Co., Ltd.. FDA's decision date was May 5, 2026, under product code OHT (Light Based Over-The-Counter Hair Removal).

Who makes the Ice Cooling IPL Hair Removal Device (UI20S DB, UI20S RE, UI20S PW, UI20S GP, UI20S GR, UI20S BK)?

Shenzhen Ulike Smart Electronics Co., Ltd., based in Shenzhen, is the applicant of record for K260742.

How long did the K260742 review take?

FDA received the submission on Mar 6, 2026 and issued its decision on May 5, 2026, 60 days later.

← All decisions in May 2026

Sources