FDA 510(k)

InstaClear Lens Cleaner

Número K: K152531 · 2016-01-15

Data da decisão2016-01-15

Código do produtoEOB

Comité consultivoEN

DecisãoSubstantially Equivalent

Resumo do dispositivo

InstaClear Lens Cleaner is the device name listed in this FDA 510(k) record. The listed applicant is Gyrus Acmi, Inc.. It received FDA 510(k) clearance on 2016-01-15 under 510(k) number K152531. The device is classified under product code EOB. It was reviewed by the EN advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the InstaClear Lens Cleaner?

InstaClear Lens Cleaner is a medical device that received FDA 510(k) clearance on 2016-01-15. The listed applicant is Gyrus Acmi, Inc.. The 510(k) number is K152531.

When did InstaClear Lens Cleaner receive FDA 510(k) clearance?

InstaClear Lens Cleaner received FDA 510(k) clearance on 2016-01-15, under 510(k) number K152531.

Who is the listed applicant for InstaClear Lens Cleaner?

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

What is the FDA product code for InstaClear Lens Cleaner?

The FDA product code for InstaClear Lens Cleaner is EOB.

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