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FDA 510(k)

窄波UV光療燈 (型號：HB-UPLL-01, HB-UPLL-02)

K 號：K223882 · 2023-03-27

申請人Shenzhen Honpal Optoelectronic Technology Co., Ltd.
決定日期2023-03-27
產品代碼FTC
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

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Honpal Optoelectronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-03-27 under 510(k) number K223882. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is a medical device that received FDA 510(k) clearance on 2023-03-27. The listed applicant is Shenzhen Honpal Optoelectronic Technology Co., Ltd.. The 510(k) number is K223882.

When did Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) receive FDA 510(k) clearance?

Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) received FDA 510(k) clearance on 2023-03-27, under 510(k) number K223882.

Who is the listed applicant for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

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

What is the FDA product code for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02)?

The FDA product code for Narrowband UV Phototherapy Light Lamp (Model: HB-UPLL-01, HB-UPLL-02) is FTC.

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相關器械（代碼：FTC）

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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