FDA 510(k)

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K番号: K153718 · 2016-02-12

決定日2016-02-12

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Spirit Hair Removal laser Family is the device name listed in this FDA 510(k) record. The listed applicant is Active Optical Systems , Ltd.. It received FDA 510(k) clearance on 2016-02-12 under 510(k) number K153718. 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.

よくある質問

What is the Spirit Hair Removal laser Family?

Spirit Hair Removal laser Family is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is Active Optical Systems , Ltd.. The 510(k) number is K153718.

When did Spirit Hair Removal laser Family receive FDA 510(k) clearance?

Spirit Hair Removal laser Family received FDA 510(k) clearance on 2016-02-12, under 510(k) number K153718.

Who is the listed applicant for Spirit Hair Removal laser Family?

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

What is the FDA product code for Spirit Hair Removal laser Family?

The FDA product code for Spirit Hair Removal laser Family is GEX. This falls under the Gastroenterology category.

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医療機器の概要

よくある質問

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