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FDA 510(k)

NutraStim Hair Laser Helmet

K-Number: K160728 · 2016-09-16

ApplicantNutra Luxe MD, LLC
Decision Date2016-09-16
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

NutraStim Hair Laser Helmet is the device name listed in this FDA 510(k) record. The listed applicant is Nutra Luxe MD, LLC. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K160728. 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 NutraStim Hair Laser Helmet?

NutraStim Hair Laser Helmet is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Nutra Luxe MD, LLC. The 510(k) number is K160728.

When did NutraStim Hair Laser Helmet receive FDA 510(k) clearance?

NutraStim Hair Laser Helmet received FDA 510(k) clearance on 2016-09-16, under 510(k) number K160728.

Who is the listed applicant for NutraStim Hair Laser Helmet?

The FDA 510(k) record lists Nutra Luxe MD, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NutraStim Hair Laser Helmet?

The FDA product code for NutraStim Hair Laser Helmet is OAP.

Other records listing Nutra Luxe MD, LLC 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.

K162371Pulsaderm ACE-All BlueK161941Pulsaderm Acne DeviceK150826Nutra Face Lift Model PE8050

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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