MyDay

Lenses, Soft Contact, Daily Wear

CooperVision, Inc.

The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Myday.

Pre-market Notification Details

• Device ID: K190965
• 510k Number: K190965
• Device Name: MyDay
• Classification: Lenses, Soft Contact, Daily Wear
• Applicant: CooperVision, Inc. 5870 Stoneridge Drive, Suite 1 Pleasanton, CA 94588
• Contact: Marie Dutton
• Correspondent: Marie Dutton; CooperVision, Inc. 5870 Stoneridge Drive, Suite 1 Pleasanton, CA 94588
• Product Code: LPL
• CFR Regulation Number: 886.5925 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-04-12
• Decision Date: 2019-04-29