FDA 510(k)

マイクロカレントフェイシャルビューティーデバイス（AM-810B、AM-810W、AM-812B、AM-812W）

K番号: K241718 · 2024-10-28

申請者Shenzhen Aozemei Technology Co., Ltd.

決定日2024-10-28

製品コードOHS

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

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

よくある質問

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. The listed applicant is Shenzhen Aozemei Technology Co., Ltd.. The 510(k) number is K241718.

When did Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) receive FDA 510(k) clearance?

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

Who is the listed applicant for Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

The FDA 510(k) record lists Shenzhen Aozemei Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

申請者としてShenzhen Aozemei Technology Co., Ltd.を記載するその他の記録

K243430マイクロカレントフェイシャルビューティーデバイス（AM-810B、AM-810W、AM-812B、AM-812W）

公式ソース

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