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FDA 510(k)

iHelmet Hair Growth System

K-Number: K162782 · 2017-04-04

ApplicantSlinph Technologies Co., Ltd.
Decision Date2017-04-04
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

iHelmet Hair Growth System is the device name listed in this FDA 510(k) record. The listed applicant is Slinph Technologies Co., Ltd.. It received FDA 510(k) clearance on 2017-04-04 under 510(k) number K162782. 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 iHelmet Hair Growth System?

iHelmet Hair Growth System is a medical device that received FDA 510(k) clearance on 2017-04-04. The listed applicant is Slinph Technologies Co., Ltd.. The 510(k) number is K162782.

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

iHelmet Hair Growth System received FDA 510(k) clearance on 2017-04-04, under 510(k) number K162782.

Who is the listed applicant for iHelmet Hair Growth System?

The FDA 510(k) record lists Slinph Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for iHelmet Hair Growth System?

The FDA product code for iHelmet Hair Growth System is OAP.

Other records listing Slinph Technologies 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.

K202631iHelmet Laser CombK190467iHelmet Hair Growth System

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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