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FDA 510(k)

InstaClear Lens Cleaner

K-Number: K152531 · 2016-01-15

ApplicantGyrus Acmi, Inc.
Decision Date2016-01-15
Product CodeEOB
Advisory CommitteeEN
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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