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FDA 510(k)

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)

K-Number: K241718 · 2024-10-28

ApplicantShenzhen Aozemei Technology Co., Ltd.
Decision Date2024-10-28
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) is a medical device manufactured by Shenzhen Aozemei Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-10-28 under approval number K241718. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) is a medical device that received FDA 510(k) clearance on 2024-10-28. It is manufactured by Shenzhen Aozemei Technology Co., Ltd.. The 510(k) number is K241718.

When was Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) approved by the FDA?

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) received FDA 510(k) clearance on 2024-10-28, under approval number K241718.

What company makes Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) is manufactured by Shenzhen Aozemei Technology Co., Ltd..

What is the FDA product code for Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

The FDA product code for Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) is OHS.

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Related PubMed Literature

PMID: 42173550 Towards a feature-based regulatory benchmark for user-centred SaMD design in cancer care. BMJ health & care informatics (2026) PMID: 41886403 Urologic Device Innovation and Trends: An Analysis of Food and Drug Administration Approvals From 1990 to 2023. Urology practice (2026) PMID: 41857339 Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority. NPJ digital medicine (2026) PMID: 41673095 Current challenges and the way forwards for regulatory databases of artificial intelligence as a medical device. NPJ digital medicine (2026)

Other Devices by Shenzhen Aozemei Technology Co., Ltd.

K243430Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)

Related Devices (Code: OHS)

K161849BrightTanda Beauty Canada, Inc. K152332Perfectio LED infrared deviceOmm Imports Inc Dba Zero Gravity K151337StrialiteCentre Light Solutions, LLC K171323BIOPHOTAS CELLUMA3Biophotas, Inc. K170984LG BEAUTY LED MASKLg Electronics K171386dpl SpectraLiteLed Technologies, Inc.

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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