FDA 510(k)

XTRAC動力氣態氫氯激光系統

K 號：K193478 · 2020-01-14

決定日期2020-01-14

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

XTRAC Momentum Excimer Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Strata Skin Sciences, Inc.. It received FDA 510(k) clearance on 2020-01-14 under 510(k) number K193478. 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 XTRAC Momentum Excimer Laser System?

XTRAC Momentum Excimer Laser System is a medical device that received FDA 510(k) clearance on 2020-01-14. The listed applicant is Strata Skin Sciences, Inc.. The 510(k) number is K193478.

When did XTRAC Momentum Excimer Laser System receive FDA 510(k) clearance?

XTRAC Momentum Excimer Laser System received FDA 510(k) clearance on 2020-01-14, under 510(k) number K193478.

Who is the listed applicant for XTRAC Momentum Excimer Laser System?

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

What is the FDA product code for XTRAC Momentum Excimer Laser System?

The FDA product code for XTRAC Momentum Excimer Laser System is GEX. This falls under the Gastroenterology category.

其他以 Strata Skin Sciences, Inc. 為申請人之記錄

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相關器械（代碼：GEX）

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