Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2025-10-30 under 510(k) 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. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K252414.

When did Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1) receive FDA 510(k) clearance?

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

Who is the listed applicant for Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)?

The FDA 510(k) record lists Shenzhen Kaiyan Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Shenzhen Kaiyan Medical Equipment Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253932FACEGYM Pro Device (HD-109)K254025LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)K260688Sculpt LED Belt (HY-150A/HY-150B/HY-200A/HY-200B/HY-420A/HY-200D/HY-200C)K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )K253878LUSTRE GoGlow Advanced LED Patches (PR8001, PR9001)K252603HIGHERDOSE Body Sculptor (Model: GS-03)

View all 24 devices →

Related Devices (Code: OAP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261675CHZL Red Light Therapy Hair Growth Cap (Model(s):CHZL-120BK-L52D,CHZL-120BK-L53D,CHZL-120BK-L54D)Shenzhen Chuanghong Zhilian Technology Co., Ltd.K261253Laser Hair Growth Devices (HR-H1, HR-H2, HR-H3, HR-H4, HR-H5, HR-H6, HR-H7, HR-H8, HR-H9, HR-H10, HR-I1, HR-I2, HR-I3, HR-I4, HR-I5)Ziree Co., Ltd.K260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)Zdeer Technology (Henan) Co., Ltd.K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)Hubei Yjt Technology Co.,LtdK251684Alma TED+ SystemAlma Lasers, Inc.K253669TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)Shenzhen Kaiyan Medical Equipment Co., Ltd.

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.

↑