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FDA 510(k)

OPTI-TEARS(R)

K-Number: K890303 · 1989-02-17

ApplicantAlcon Laboratories
Decision Date1989-02-17
Product CodeLPN
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

OPTI-TEARS(R) is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories. It received FDA 510(k) clearance on 1989-02-17 under 510(k) number K890303. 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 OPTI-TEARS(R)?

OPTI-TEARS(R) is a medical device that received FDA 510(k) clearance on 1989-02-17. The listed applicant is Alcon Laboratories. The 510(k) number is K890303.

When did OPTI-TEARS(R) receive FDA 510(k) clearance?

OPTI-TEARS(R) received FDA 510(k) clearance on 1989-02-17, under 510(k) number K890303.

Who is the listed applicant for OPTI-TEARS(R)?

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

What is the FDA product code for OPTI-TEARS(R)?

The FDA product code for OPTI-TEARS(R) is LPN.

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Other records listing Alcon Laboratories 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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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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