FDA 510(k)

Lumix超級1，Lumix超級2，Lumix超級3

K 號：K161198 · 2016-07-26

決定日期2016-07-26

產品代碼ILY

諮詢委員會PM

決定相當於

器材摘要

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 is the device name listed in this FDA 510(k) record. The listed applicant is Usa Laser Biotech, Inc.. It received FDA 510(k) clearance on 2016-07-26 under 510(k) number K161198. The device is classified under product code ILY. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3?

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 is a medical device that received FDA 510(k) clearance on 2016-07-26. The listed applicant is Usa Laser Biotech, Inc.. The 510(k) number is K161198.

When did Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 receive FDA 510(k) clearance?

Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 received FDA 510(k) clearance on 2016-07-26, under 510(k) number K161198.

Who is the listed applicant for Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3?

The FDA 510(k) record lists Usa Laser Biotech, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3?

The FDA product code for Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 is ILY.

其他以 Usa Laser Biotech, Inc. 為申請人之記錄

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相關器械（代碼：ILY）

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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