FDA 510(k)

TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)

K-Number: K253669 · 2026-01-23

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.

Decision Date2026-01-23

Product CodeOAP

Advisory CommitteePM

DecisionSubstantially Equivalent

Device Summary

TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-01-23 under approval number K253669. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)?

TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) is a medical device that received FDA 510(k) clearance on 2026-01-23. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K253669.

When was TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) approved by the FDA?

TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) received FDA 510(k) clearance on 2026-01-23, under approval number K253669.

What company makes TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)?

TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

What is the FDA product code for TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)?

The FDA product code for TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300) is OAP.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.