FDA 510(k)

Beurer IPL 8500 device/ IPL VelvetSkin Pro

N.º K: K181734 · 2018-09-19

Fecha de decisión2018-09-19

Código de productoOHT

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Beurer IPL 8500 device/ IPL VelvetSkin Pro is the device name listed in this FDA 510(k) record. The listed applicant is Home Well Trading, Ltd.. It received FDA 510(k) clearance on 2018-09-19 under 510(k) number K181734. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Beurer IPL 8500 device/ IPL VelvetSkin Pro?

Beurer IPL 8500 device/ IPL VelvetSkin Pro is a medical device that received FDA 510(k) clearance on 2018-09-19. The listed applicant is Home Well Trading, Ltd.. The 510(k) number is K181734.

When did Beurer IPL 8500 device/ IPL VelvetSkin Pro receive FDA 510(k) clearance?

Beurer IPL 8500 device/ IPL VelvetSkin Pro received FDA 510(k) clearance on 2018-09-19, under 510(k) number K181734.

Who is the listed applicant for Beurer IPL 8500 device/ IPL VelvetSkin Pro?

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

What is the FDA product code for Beurer IPL 8500 device/ IPL VelvetSkin Pro?

The FDA product code for Beurer IPL 8500 device/ IPL VelvetSkin Pro is OHT.

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Otros registros que enlistan a Home Well Trading, Ltd. como solicitante

K181121Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro

Dispositivos relacionados (Código: OHT)

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Fuente oficial

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