FDA 510(k)

InMode System with Fractora3D/3D-90 Applicators

N.º K: K180189 · 2018-06-01

Fecha de decisión2018-06-01

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

InMode System with Fractora3D/3D-90 Applicators is the device name listed in this FDA 510(k) record. The listed applicant is Inmode MD , Ltd.. It received FDA 510(k) clearance on 2018-06-01 under 510(k) number K180189. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the InMode System with Fractora3D/3D-90 Applicators?

InMode System with Fractora3D/3D-90 Applicators is a medical device that received FDA 510(k) clearance on 2018-06-01. The listed applicant is Inmode MD , Ltd.. The 510(k) number is K180189.

When did InMode System with Fractora3D/3D-90 Applicators receive FDA 510(k) clearance?

InMode System with Fractora3D/3D-90 Applicators received FDA 510(k) clearance on 2018-06-01, under 510(k) number K180189.

Who is the listed applicant for InMode System with Fractora3D/3D-90 Applicators?

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

What is the FDA product code for InMode System with Fractora3D/3D-90 Applicators?

The FDA product code for InMode System with Fractora3D/3D-90 Applicators is GEI.

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Fuente oficial

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