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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 / November 2025 / K253304

510(k) cleared

IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)

Dongguan Lide Electric Appliance Co., Ltd. · Nov 25, 2025 · K253304

FDA cleared the IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C) from Dongguan Lide Electric Appliance Co., Ltd. on Nov 25, 2025 under K253304, 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 Sep 29, 2025. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K253304?

K253304 is the FDA 510(k) for IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C), submitted by Dongguan Lide Electric Appliance Co., Ltd.. FDA's decision date was Nov 25, 2025, under product code OHT (Light Based Over-The-Counter Hair Removal).

Who makes the IPL Hair Removal Device (KA-10, KA-11, KA-11C, KA-11D, KA-18, KA-20, KA-21, KA-21C)?

Dongguan Lide Electric Appliance Co., Ltd., based in Dongguan, is the applicant of record for K253304.

How long did the K253304 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Nov 25, 2025, 57 days later.

← All decisions in November 2025