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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 / K253035

510(k) cleared

IPL Hair Removal Device (SYL001AZ, SYL002AZ)

Gu'An Yeolight Smart Electronics Co., Ltd. · Nov 19, 2025 · K253035

FDA cleared the IPL Hair Removal Device (SYL001AZ, SYL002AZ) from Gu'An Yeolight Smart Electronics Co., Ltd. on Nov 19, 2025 under K253035, 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 22, 2025. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Gu'An Yeolight Smart Electronics Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253035?

K253035 is the FDA 510(k) for IPL Hair Removal Device (SYL001AZ, SYL002AZ), submitted by Gu'An Yeolight Smart Electronics Co., Ltd.. FDA's decision date was Nov 19, 2025, under product code OHT (Light Based Over-The-Counter Hair Removal).

Who makes the IPL Hair Removal Device (SYL001AZ, SYL002AZ)?

Gu'An Yeolight Smart Electronics Co., Ltd., based in Langfang, is the applicant of record for K253035.

How long did the K253035 review take?

FDA received the submission on Sep 22, 2025 and issued its decision on Nov 19, 2025, 58 days later.

← All decisions in November 2025