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FDA 510(k)

OPTI-FREE EXPRESS LENS DROPS

K-Number: K000385 · 2000-04-28

ApplicantAlcon Universal, Ltd.
Decision Date2000-04-28
Product CodeMRC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTI-FREE EXPRESS LENS DROPS is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Universal, Ltd.. It received FDA 510(k) clearance on 2000-04-28 under 510(k) number K000385. The device is classified under product code MRC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTI-FREE EXPRESS LENS DROPS?

OPTI-FREE EXPRESS LENS DROPS is a medical device that received FDA 510(k) clearance on 2000-04-28. The listed applicant is Alcon Universal, Ltd.. The 510(k) number is K000385.

When did OPTI-FREE EXPRESS LENS DROPS receive FDA 510(k) clearance?

OPTI-FREE EXPRESS LENS DROPS received FDA 510(k) clearance on 2000-04-28, under 510(k) number K000385.

Who is the listed applicant for OPTI-FREE EXPRESS LENS DROPS?

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

What is the FDA product code for OPTI-FREE EXPRESS LENS DROPS?

The FDA product code for OPTI-FREE EXPRESS LENS DROPS is MRC.

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Other records listing Alcon Universal, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: MRC)

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Official Source

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

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