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The Tracker / September 2026 / K262183

510(k) cleared

Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)

Shenzhen Nuon Medical Equipment Co., Ltd. · Sep 24, 2026 · K262183

FDA cleared the Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60) from Shenzhen Nuon Medical Equipment Co., Ltd. on Sep 24, 2026 under K262183, 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 Jun 29, 2026. The decision came 87 days later, inside the 90 FDA-day goal for a 510(k).

Shenzhen Nuon Medical Equipment Co., Ltd. has one other decision in the tracker over the last 12 months: K251034 (Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70); Radiant Renewal Skincare Wand (HD-44)).

Questions & Answers

What did FDA clear under K262183?

K262183 is the FDA 510(k) for Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60), submitted by Shenzhen Nuon Medical Equipment Co., Ltd.. FDA's decision date was Sep 24, 2026, under product code OAP (Laser, Comb, Hair).

Who makes the Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)?

Shenzhen Nuon Medical Equipment Co., Ltd., based in Shenzhen, is the applicant of record for K262183.

How long did the K262183 review take?

FDA received the submission on Jun 29, 2026 and issued its decision on Sep 24, 2026, 87 days later.

← All decisions in September 2026

Sources