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FDA 510(k)

iRestore

K-Number: K151662 · 2016-01-06

ApplicantFreedom Laser Therapy, Inc.
Decision Date2016-01-06
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

iRestore is the device name listed in this FDA 510(k) record. The listed applicant is Freedom Laser Therapy, Inc.. It received FDA 510(k) clearance on 2016-01-06 under 510(k) number K151662. 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 iRestore?

iRestore is a medical device that received FDA 510(k) clearance on 2016-01-06. The listed applicant is Freedom Laser Therapy, Inc.. The 510(k) number is K151662.

When did iRestore receive FDA 510(k) clearance?

iRestore received FDA 510(k) clearance on 2016-01-06, under 510(k) number K151662.

Who is the listed applicant for iRestore?

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

What is the FDA product code for iRestore?

The FDA product code for iRestore is OAP.

Other records listing Freedom Laser Therapy, 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.

K222081ID-510 iRestore EliteK213094ID-500 iRestore Hair Growth SystemK183417iRestore Professional 282

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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