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FDA 510(k)

微電流臉部美容設備（AM-810B、AM-810W、AM-812B、AM-812W）

K 號：K243430 · 2024-12-19

申請人Shenzhen Aozemei Technology Co., Ltd.
決定日期2024-12-19
產品代碼NFO
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

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 2024-12-19 under 510(k) number K243430. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

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 2024-12-19. The listed applicant is Shenzhen Aozemei Technology Co., Ltd.. The 510(k) number is K243430.

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 2024-12-19, under 510(k) number K243430.

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 NFO.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Shenzhen Aozemei Technology Co., Ltd. 為申請人之記錄

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K241718微電流臉部美容設備（AM-810B、AM-810W、AM-812B、AM-812W）

相關器械（代碼：NFO）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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官方來源

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