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FDA 510(k)

Neuhat Hair Growth System; ibeauty.com Laser Cap

K-Number: K231153 · 2023-06-23

ApplicantNature, Inc.redible, Inc.
Decision Date2023-06-23
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Neuhat Hair Growth System; ibeauty.com Laser Cap is the device name listed in this FDA 510(k) record. The listed applicant is Nature, Inc.redible, Inc.. It received FDA 510(k) clearance on 2023-06-23 under 510(k) number K231153. 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 Neuhat Hair Growth System; ibeauty.com Laser Cap?

Neuhat Hair Growth System; ibeauty.com Laser Cap is a medical device that received FDA 510(k) clearance on 2023-06-23. The listed applicant is Nature, Inc.redible, Inc.. The 510(k) number is K231153.

When did Neuhat Hair Growth System; ibeauty.com Laser Cap receive FDA 510(k) clearance?

Neuhat Hair Growth System; ibeauty.com Laser Cap received FDA 510(k) clearance on 2023-06-23, under 510(k) number K231153.

Who is the listed applicant for Neuhat Hair Growth System; ibeauty.com Laser Cap?

The FDA 510(k) record lists Nature, Inc.redible, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Neuhat Hair Growth System; ibeauty.com Laser Cap?

The FDA product code for Neuhat Hair Growth System; ibeauty.com Laser Cap is OAP.

Related Clinical Trials

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.

NCT03491267Study to Determine Effect of Gentle Wounding to Stimulate Hair Follicle NeogenesisCOMPLETED

Other records listing Nature, Inc.redible, Inc. 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.

K201854CAPOGEN Laser Cap

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

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

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