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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 / October 2025 / K252209

510(k) cleared

IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)

Foshan Jindi Electric Appliance Co., Ltd. · Oct 10, 2025 · K252209

FDA cleared the IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032) from Foshan Jindi Electric Appliance Co., Ltd. on Oct 10, 2025 under K252209, 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 Jul 15, 2025. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Foshan Jindi Electric Appliance Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252209?

K252209 is the FDA 510(k) for IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032), submitted by Foshan Jindi Electric Appliance Co., Ltd.. FDA's decision date was Oct 10, 2025, under product code OHT (Light Based Over-The-Counter Hair Removal).

Who makes the IPL Home Use Hair Removal Device (JD-TM016, JD-TM023, JD-TM027, JD-TM028, JD-TM032)?

Foshan Jindi Electric Appliance Co., Ltd., based in Foshan, is the applicant of record for K252209.

How long did the K252209 review take?

FDA received the submission on Jul 15, 2025 and issued its decision on Oct 10, 2025, 87 days later.

← All decisions in October 2025