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FDA 510(k)

Hair Up

K-Number: K180617 · 2018-06-01

ApplicantY & J Bio Co., Ltd.
Decision Date2018-06-01
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Hair Up is the device name listed in this FDA 510(k) record. The listed applicant is Y & J Bio Co., Ltd.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180617. 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 Hair Up?

Hair Up is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Y & J Bio Co., Ltd.. The 510(k) number is K180617.

When did Hair Up receive FDA 510(k) clearance?

Hair Up received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180617.

Who is the listed applicant for Hair Up?

The FDA 510(k) record lists Y & J Bio Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hair Up?

The FDA product code for Hair Up is OAP.

Other records listing Y & J Bio 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.

K223278easy ClaireK213285easy ClaireK202983easy HairfullK172968Hair Up

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.

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