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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 / December 2025 / K253754

510(k) cleared

Philips Lumea IPL

Philips Consumer Lifestyle B.V. · Dec 23, 2025 · K253754

FDA cleared the Philips Lumea IPL from Philips Consumer Lifestyle B.V. on Dec 23, 2025 under K253754, 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 Nov 25, 2025. The decision came 28 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Philips Consumer Lifestyle B.V. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253754?

K253754 is the FDA 510(k) for Philips Lumea IPL, submitted by Philips Consumer Lifestyle B.V.. FDA's decision date was Dec 23, 2025, under product code OHT (Light Based Over-The-Counter Hair Removal).

Who makes the Philips Lumea IPL?

Philips Consumer Lifestyle B.V., based in Drachten, is the applicant of record for K253754.

How long did the K253754 review take?

FDA received the submission on Nov 25, 2025 and issued its decision on Dec 23, 2025, 28 days later.

← All decisions in December 2025