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FDA 510(k)

Hair Laser Headband

K-Number: K182501 · 2018-10-26

ApplicantPulsaderm, LLC
Decision Date2018-10-26
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Hair Laser Headband is the device name listed in this FDA 510(k) record. The listed applicant is Pulsaderm, LLC. It received FDA 510(k) clearance on 2018-10-26 under 510(k) number K182501. 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 Laser Headband?

Hair Laser Headband is a medical device that received FDA 510(k) clearance on 2018-10-26. The listed applicant is Pulsaderm, LLC. The 510(k) number is K182501.

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

Hair Laser Headband received FDA 510(k) clearance on 2018-10-26, under 510(k) number K182501.

Who is the listed applicant for Hair Laser Headband?

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

What is the FDA product code for Hair Laser Headband?

The FDA product code for Hair Laser Headband is OAP.

Other records listing Pulsaderm, 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.

K170111Pulsaderm Acne Mask 28 , Pulsaderm Acne Mask 37K163329Pulsaderm Wrinkle Mask 28, Pulsaderm Wrinkle Mask 72

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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