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FDA 510(k)

Hair Growth System

K-Number: K191754 · 2019-11-22

ApplicantKunshan Bella Optical Technology Co., Ltd.
Decision Date2019-11-22
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Hair Growth System is the device name listed in this FDA 510(k) record. The listed applicant is Kunshan Bella Optical Technology Co., Ltd.. It received FDA 510(k) clearance on 2019-11-22 under 510(k) number K191754. 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 Growth System?

Hair Growth System is a medical device that received FDA 510(k) clearance on 2019-11-22. The listed applicant is Kunshan Bella Optical Technology Co., Ltd.. The 510(k) number is K191754.

When did Hair Growth System receive FDA 510(k) clearance?

Hair Growth System received FDA 510(k) clearance on 2019-11-22, under 510(k) number K191754.

Who is the listed applicant for Hair Growth System?

The FDA 510(k) record lists Kunshan Bella Optical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hair Growth System?

The FDA product code for Hair Growth System is OAP.

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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