FDA 510(k)

LightMed Dental Laser System

N.º K: K170073 · 2017-07-25

SolicitanteLightmed Dentaltechnology Corp.

Fecha de decisión2017-07-25

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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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Fuente oficial

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