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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 / K261675

510(k) cleared

CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)

Shenzhen Chuanghong Zhilian Technology Co., Ltd. · Jul 17, 2026 · K261675

FDA cleared the CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D) from Shenzhen Chuanghong Zhilian Technology Co., Ltd. on Jul 17, 2026 under K261675, a traditional 510(k). The device falls under product code OAP, Laser, Comb, Hair, regulated at 21 CFR 890.5500 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on May 21, 2026. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Shenzhen Chuanghong Zhilian Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261675?

K261675 is the FDA 510(k) for CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D), submitted by Shenzhen Chuanghong Zhilian Technology Co., Ltd.. FDA's decision date was Jul 17, 2026, under product code OAP (Laser, Comb, Hair).

Who makes the CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)?

Shenzhen Chuanghong Zhilian Technology Co., Ltd., based in Shenzhen, is the applicant of record for K261675.

How long did the K261675 review take?

FDA received the submission on May 21, 2026 and issued its decision on Jul 17, 2026, 57 days later.

← All decisions in July 2026