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FDA 510(k)

Auxo A300, A150 and APod

K-Number: K220543 · 2022-04-20

ApplicantAuxo Hair, LLC
Decision Date2022-04-20
Product CodeOAP
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Auxo A300, A150 and APod is the device name listed in this FDA 510(k) record. The listed applicant is Auxo Hair, LLC. It received FDA 510(k) clearance on 2022-04-20 under 510(k) number K220543. 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 Auxo A300, A150 and APod?

Auxo A300, A150 and APod is a medical device that received FDA 510(k) clearance on 2022-04-20. The listed applicant is Auxo Hair, LLC. The 510(k) number is K220543.

When did Auxo A300, A150 and APod receive FDA 510(k) clearance?

Auxo A300, A150 and APod received FDA 510(k) clearance on 2022-04-20, under 510(k) number K220543.

Who is the listed applicant for Auxo A300, A150 and APod?

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

What is the FDA product code for Auxo A300, A150 and APod?

The FDA product code for Auxo A300, A150 and APod is OAP.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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