FDA 510(k)

Dawn二極管雷射系統

K 號：K232885 · 2024-02-28

申請人Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd

決定日期2024-02-28

產品代碼NVK

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

Dawn Diode Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. It received FDA 510(k) clearance on 2024-02-28 under 510(k) number K232885. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Dawn Diode Laser System?

Dawn Diode Laser System is a medical device that received FDA 510(k) clearance on 2024-02-28. The listed applicant is Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd. The 510(k) number is K232885.

When did Dawn Diode Laser System receive FDA 510(k) clearance?

Dawn Diode Laser System received FDA 510(k) clearance on 2024-02-28, under 510(k) number K232885.

Who is the listed applicant for Dawn Diode Laser System?

The FDA 510(k) record lists Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dawn Diode Laser System?

The FDA product code for Dawn Diode Laser System is NVK.

其他以 Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd 為申請人之記錄

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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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