FDA 510(k)

LightSheer Desire；LightSheer Desire Light；LightSheer Duet；LightSheer Infinity

K 號：K170179 · 2017-09-18

決定日期2017-09-18

產品代碼GEX

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

LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity is the device name listed in this FDA 510(k) record. The listed applicant is Lumenis, Ltd.. It received FDA 510(k) clearance on 2017-09-18 under 510(k) number K170179. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

常見問題

What is the LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity?

LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity is a medical device that received FDA 510(k) clearance on 2017-09-18. The listed applicant is Lumenis, Ltd.. The 510(k) number is K170179.

When did LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity receive FDA 510(k) clearance?

LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity received FDA 510(k) clearance on 2017-09-18, under 510(k) number K170179.

Who is the listed applicant for LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity?

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

What is the FDA product code for LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity?

The FDA product code for LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity is GEX. This falls under the Gastroenterology category.

其他以 Lumenis, 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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