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

FDA Premarket Approval P180035 S015

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

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.5870 Stoneridge Drivesuite 1pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS015 Date Received12/19/2022 Decision Date01/13/2023 Product Code QIT  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No
Date Received2022-12-19
Decision Date2023-01-13
PMAP180035
SupplementS015
Product CodeQIT 
Advisory CommitteeOphthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol
Expedited ReviewNo
Combination ProductNo
Applicant AddressCooperVision, Inc.
5870 Stoneridge Drive
suite 1
pleasanton, CA 94588 PMA NumberP180035 Supplement NumberS015 Date Received12/19/2022 Decision Date01/13/2023 Product Code QIT  Advisory Committee Ophthalmic Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Revision Of PAS002 Protocol V4.0

Supplemental Filings

Supplement NumberDateSupplement Type
P180035Original Filing
S015 2022-12-19 Normal 180 Day Track No User Fee
S014 2022-12-16 30-day Notice
S013 2022-12-14 30-day Notice
S012 2022-09-30 Normal 180 Day Track No User Fee
S011 2022-08-23 30-day Notice
S010 2022-08-17 30-day Notice
S009 2021-12-29 30-day Notice
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
S004
S003
S002 2020-01-09 30-day Notice
S001 2019-11-29 Normal 180 Day Track No User Fee

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