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FDA 510(k)

IGROW II HAIR GROWTH SYSTEM

K-Number: K122248 · 2012-12-05

ApplicantApira Science, Inc.
Decision Date2012-12-05
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

IGROW II HAIR GROWTH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Apira Science, Inc.. It received FDA 510(k) clearance on 2012-12-05 under 510(k) number K122248. 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 IGROW II HAIR GROWTH SYSTEM?

IGROW II HAIR GROWTH SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-05. The listed applicant is Apira Science, Inc.. The 510(k) number is K122248.

When did IGROW II HAIR GROWTH SYSTEM receive FDA 510(k) clearance?

IGROW II HAIR GROWTH SYSTEM received FDA 510(k) clearance on 2012-12-05, under 510(k) number K122248.

Who is the listed applicant for IGROW II HAIR GROWTH SYSTEM?

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

What is the FDA product code for IGROW II HAIR GROWTH SYSTEM?

The FDA product code for IGROW II HAIR GROWTH SYSTEM 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.

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Other records listing Apira Science, 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.

K242619GroWell BT Hair Growth System (GW10042)

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.

K262183Hair Growth Helmet (TK-176, TK-600, TK-500, TK-282, TK-500A, TK-282A, TK-126, TK-60)Shenzhen Nuon Medical Equipment Co., Ltd.K262254Hair Growth Comb (X-GC01)Guangdong Ashmore Health Technology Co., Ltd.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.K253231Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)Hubei Yjt Technology Co.,LtdK260899Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)Zdeer Technology (Henan) 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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