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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / July 2026 / K261482

510(k) cleared

LightStim for Wrinkles (1984); LightStim for Acne (2038)

Led Intellectual Properties, LLC · Jul 31, 2026 · K261482

FDA cleared the LightStim for Wrinkles (1984); LightStim for Acne (2038) from Led Intellectual Properties, LLC on Jul 31, 2026 under K261482, a traditional 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 May 5, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Led Intellectual Properties, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261482?

K261482 is the FDA 510(k) for LightStim for Wrinkles (1984); LightStim for Acne (2038), submitted by Led Intellectual Properties, LLC. FDA's decision date was Jul 31, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the LightStim for Wrinkles (1984); LightStim for Acne (2038)?

Led Intellectual Properties, LLC, based in Irvine, CA, is the applicant of record for K261482.

How long did the K261482 review take?

FDA received the submission on May 5, 2026 and issued its decision on Jul 31, 2026, 87 days later.

← All decisions in July 2026