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FDA 510(k)

紅外線療法導引臉部光療面膜-Derma plus，光子臉部皮膚護理機LED美妝面膜療法機器

K 號：K200983 · 2021-07-14

申請人Ningbo Hesi Electric Co., Ltd.
決定日期2021-07-14
產品代碼OHS
諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。
決定相當於

器材摘要

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine is the device name listed in this FDA 510(k) record. The listed applicant is Ningbo Hesi Electric Co., Ltd.. It received FDA 510(k) clearance on 2021-07-14 under 510(k) number K200983. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine?

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine is a medical device that received FDA 510(k) clearance on 2021-07-14. The listed applicant is Ningbo Hesi Electric Co., Ltd.. The 510(k) number is K200983.

When did Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine receive FDA 510(k) clearance?

Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine received FDA 510(k) clearance on 2021-07-14, under 510(k) number K200983.

Who is the listed applicant for Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine?

The FDA 510(k) record lists Ningbo Hesi Electric Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine?

The FDA product code for Infrared light therapy led facial light therapy mask-Derma plus, Photons Facial Skin Care Machine LED Beauty Mask Therapy Beauty Machine is OHS.

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。

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相關器械（代碼：OHS）

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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