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FDA 510(k)

AOCup Lens Case with AODisc

K-Number: K191795 · 2019-07-31

ApplicantAlcon Laboratories, Inc.
Decision Date2019-07-31
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AOCup Lens Case with AODisc is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2019-07-31 under 510(k) number K191795. The device is classified under product code LPN. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AOCup Lens Case with AODisc?

AOCup Lens Case with AODisc is a medical device that received FDA 510(k) clearance on 2019-07-31. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K191795.

When did AOCup Lens Case with AODisc receive FDA 510(k) clearance?

AOCup Lens Case with AODisc received FDA 510(k) clearance on 2019-07-31, under 510(k) number K191795.

Who is the listed applicant for AOCup Lens Case with AODisc?

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

What is the FDA product code for AOCup Lens Case with AODisc?

The FDA product code for AOCup Lens Case with AODisc is LPN.

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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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