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

FDA Premarket Approval P180035 S006

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

Approval for a change in refractive index specification.

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 Received2020-04-17
Decision Date2020-06-25
PMAP180035
SupplementS006
Product CodeQIT 
Advisory CommitteeOphthalmic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address CooperVision, Inc. 5870 Stoneridge Drive suite 1 pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P180035Original Filing
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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