FDA 510(k)

超輕薄數位型，超平滑數位型

K 號：K202361 · 2020-12-18

決定日期2020-12-18

產品代碼OLI

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

UltraSlim Digital, UltraSmooth Digital is the device name listed in this FDA 510(k) record. The listed applicant is Ward Photonics, LLC. It received FDA 510(k) clearance on 2020-12-18 under 510(k) number K202361. The device is classified under product code OLI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the UltraSlim Digital, UltraSmooth Digital?

UltraSlim Digital, UltraSmooth Digital is a medical device that received FDA 510(k) clearance on 2020-12-18. The listed applicant is Ward Photonics, LLC. The 510(k) number is K202361.

When did UltraSlim Digital, UltraSmooth Digital receive FDA 510(k) clearance?

UltraSlim Digital, UltraSmooth Digital received FDA 510(k) clearance on 2020-12-18, under 510(k) number K202361.

Who is the listed applicant for UltraSlim Digital, UltraSmooth Digital?

The FDA 510(k) record lists Ward Photonics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UltraSlim Digital, UltraSmooth Digital?

The FDA product code for UltraSlim Digital, UltraSmooth Digital is OLI.

其他以 Ward Photonics, LLC 為申請人之記錄

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相關器械（代碼：OLI）

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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