FDA 510(k)

라이트메드 치과 레이저 시스템

K-번호: K170073 · 2017-07-25

결정일2017-07-25

제품 코드GEX

자문 위원회SU

결정Substantially Equivalent

기기 요약

LightMed Dental Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Lightmed Dentaltechnology Corp.. It received FDA 510(k) clearance on 2017-07-25 under 510(k) number K170073. 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 LightMed Dental Laser System?

LightMed Dental Laser System is a medical device that received FDA 510(k) clearance on 2017-07-25. The listed applicant is Lightmed Dentaltechnology Corp.. The 510(k) number is K170073.

When did LightMed Dental Laser System receive FDA 510(k) clearance?

LightMed Dental Laser System received FDA 510(k) clearance on 2017-07-25, under 510(k) number K170073.

Who is the listed applicant for LightMed Dental Laser System?

The FDA 510(k) record lists Lightmed Dentaltechnology Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LightMed Dental Laser System?

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

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라이트메드 치과 레이저 시스템

기기 요약

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관련 임상시험

관련 기기 (코드: GEX)

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