FDA 510(k)

水激光系統家族

K 號：K190319 · 2019-10-10

決定日期2019-10-10

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

Waterlase Laser System Family is the device name listed in this FDA 510(k) record. The listed applicant is Biolase, Inc.. It received FDA 510(k) clearance on 2019-10-10 under 510(k) number K190319. 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 Waterlase Laser System Family?

Waterlase Laser System Family is a medical device that received FDA 510(k) clearance on 2019-10-10. The listed applicant is Biolase, Inc.. The 510(k) number is K190319.

When did Waterlase Laser System Family receive FDA 510(k) clearance?

Waterlase Laser System Family received FDA 510(k) clearance on 2019-10-10, under 510(k) number K190319.

Who is the listed applicant for Waterlase Laser System Family?

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

What is the FDA product code for Waterlase Laser System Family?

The FDA product code for Waterlase Laser System Family is GEX. This falls under the Gastroenterology category.

其他以 Biolase, Inc. 為申請人之記錄

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