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FDA 510(k)

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)

K-Number: K252414 · 2025-10-30

ApplicantShenzhen Kaiyan Medical Equipment Co., Ltd.
Decision Date2025-10-30
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) is a medical device manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-10-30 under approval number K252414. 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 Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)?

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) is a medical device that received FDA 510(k) clearance on 2025-10-30. It is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K252414.

When was Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) approved by the FDA?

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) received FDA 510(k) clearance on 2025-10-30, under approval number K252414.

What company makes Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)?

Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) is manufactured by Shenzhen Kaiyan Medical Equipment Co., Ltd..

What is the FDA product code for Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)?

The FDA product code for Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) 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.

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