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FDA 510(k)

MyDay

K-Number: K190965 · 2019-04-29

Decision Date2019-04-29
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MyDay is the device name listed in this FDA 510(k) record. The listed applicant is CooperVision, Inc.. It received FDA 510(k) clearance on 2019-04-29 under 510(k) number K190965. 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 MyDay?

MyDay is a medical device that received FDA 510(k) clearance on 2019-04-29. The listed applicant is CooperVision, Inc.. The 510(k) number is K190965.

When did MyDay receive FDA 510(k) clearance?

MyDay received FDA 510(k) clearance on 2019-04-29, under 510(k) number K190965.

Who is the listed applicant for MyDay?

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

What is the FDA product code for MyDay?

The FDA product code for MyDay is LPL.

Related Clinical Trials

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.

Other records listing CooperVision, 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.

View all 15 devices →

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