FDA 510(k)

LED Eye Perfector, model: EY-36A, EY-36B

N.º K: K221444 · 2022-12-08

SolicitanteLight Tree Ventures Europe B.V.

Fecha de decisión2022-12-08

Código de productoOHS

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

LED Eye Perfector, model: EY-36A, EY-36B is the device name listed in this FDA 510(k) record. The listed applicant is Light Tree Ventures Europe B.V.. It received FDA 510(k) clearance on 2022-12-08 under 510(k) number K221444. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LED Eye Perfector, model: EY-36A, EY-36B?

LED Eye Perfector, model: EY-36A, EY-36B is a medical device that received FDA 510(k) clearance on 2022-12-08. The listed applicant is Light Tree Ventures Europe B.V.. The 510(k) number is K221444.

When did LED Eye Perfector, model: EY-36A, EY-36B receive FDA 510(k) clearance?

LED Eye Perfector, model: EY-36A, EY-36B received FDA 510(k) clearance on 2022-12-08, under 510(k) number K221444.

Who is the listed applicant for LED Eye Perfector, model: EY-36A, EY-36B?

The FDA 510(k) record lists Light Tree Ventures Europe B.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Eye Perfector, model: EY-36A, EY-36B?

The FDA product code for LED Eye Perfector, model: EY-36A, EY-36B is OHS.

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Fuente oficial

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