FDA 510(k)

쿨라이드 에스테틱 레이저 시리즈

K-번호: K153671 · 2016-03-09

결정일2016-03-09

제품 코드GEX

자문 위원회SU [원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

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기기 요약

Family of CoolGlide Aesthetic Lasers is the device name listed in this FDA 510(k) record. The listed applicant is Cutera, Inc.. It received FDA 510(k) clearance on 2016-03-09 under 510(k) number K153671. 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.

자주 묻는 질문

What is the Family of CoolGlide Aesthetic Lasers?

Family of CoolGlide Aesthetic Lasers is a medical device that received FDA 510(k) clearance on 2016-03-09. The listed applicant is Cutera, Inc.. The 510(k) number is K153671.

When did Family of CoolGlide Aesthetic Lasers receive FDA 510(k) clearance?

Family of CoolGlide Aesthetic Lasers received FDA 510(k) clearance on 2016-03-09, under 510(k) number K153671.

Who is the listed applicant for Family of CoolGlide Aesthetic Lasers?

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

What is the FDA product code for Family of CoolGlide Aesthetic Lasers?

The FDA product code for Family of CoolGlide Aesthetic Lasers is GEX. This falls under the Gastroenterology category.

Cutera, Inc.를 신청인으로 등재한 기타 기록

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