FDA 510(k)

Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro

Número K: K181121 · 2018-06-28

Data da decisão2018-06-28

Código do produtoOHT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin 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 2018-06-28 under 510(k) number K181121. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro?

Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro is a medical device that received FDA 510(k) clearance on 2018-06-28. The listed applicant is Home Well Trading, Ltd.. The 510(k) number is K181121.

When did Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro receive FDA 510(k) clearance?

Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro received FDA 510(k) clearance on 2018-06-28, under 510(k) number K181121.

Who is the listed applicant for Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin 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 5500 device/ IPL 5000/ IPL PureSkin Pro?

The FDA product code for Beurer IPL 5500 device/ IPL 5000/ IPL PureSkin Pro is OHT.

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Outros registros que listam Home Well Trading, Ltd. como candidato(a)

K181734Beurer IPL 8500 device/ IPL VelvetSkin Pro

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