MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

FDA Premarket Approval P180035 S008

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Introducing an alternative supplier of sealer heads used in the blister sealing process

DeviceMiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Generic NameDaily Wear Soft Contact Lens To Reduce The Progression Of Myopia
ApplicantCooperVision, Inc.
Date Received2021-03-08
Decision Date2021-03-26
Product CodeQIT 
Advisory CommitteeOphthalmic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address CooperVision, Inc. 5870 Stoneridge Drive suite 1 pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P180035Original Filing
S008 2021-03-08 30-day Notice
S007 2021-03-05 30-day Notice
S006 2020-04-17 Real-time Process
S005 2020-02-13 30-day Notice
S002 2020-01-09 30-day Notice
S001 2019-11-29 Normal 180 Day Track No User Fee

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