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FDA 510(k)

DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives

K-Number: K190045 · 2019-02-06

Decision Date2019-02-06
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives 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 2019-02-06 under 510(k) number K190045. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives?

DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives is a medical device that received FDA 510(k) clearance on 2019-02-06. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K190045.

When did DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives receive FDA 510(k) clearance?

DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives received FDA 510(k) clearance on 2019-02-06, under 510(k) number K190045.

Who is the listed applicant for DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives?

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 DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives?

The FDA product code for DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives is LPL.

Other records listing Alcon Laboratories, Inc. 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: LPL)

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.

Official Source

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