FDA 510(k)

InMode System with the Morpheus8 90 Applicator

N.º K: K240017 · 2024-06-13

Fecha de decisión2024-06-13

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

InMode System with the Morpheus8 90 Applicator is the device name listed in this FDA 510(k) record. The listed applicant is InMode , Ltd.. It received FDA 510(k) clearance on 2024-06-13 under 510(k) number K240017. 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 the Morpheus8 90 Applicator?

InMode System with the Morpheus8 90 Applicator is a medical device that received FDA 510(k) clearance on 2024-06-13. The listed applicant is InMode , Ltd.. The 510(k) number is K240017.

When did InMode System with the Morpheus8 90 Applicator receive FDA 510(k) clearance?

InMode System with the Morpheus8 90 Applicator received FDA 510(k) clearance on 2024-06-13, under 510(k) number K240017.

Who is the listed applicant for InMode System with the Morpheus8 90 Applicator?

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

What is the FDA product code for InMode System with the Morpheus8 90 Applicator?

The FDA product code for InMode System with the Morpheus8 90 Applicator is GEI.

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Fuente oficial

Ver en la base de datos de la FDA →

Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.