Home / 510(k) Clearances / K191763

510(k) K191763

MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) MULTIFOCAL, MyDay (Stenfilcon A) MULTIFOCAL TORIC by CooperVision, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 23, 2020
Date Received
July 1, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lenses, Soft Contact, Daily Wear
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

Other clearances by CooperVision, Inc.

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  • K213164 — Avaira Vitality (October 26, 2021)
  • K202756 — Clariti 1 Day (somofilcon A), Clariti 1 Day Toric (somofilcon A), Clariti 1 Day (October 20, 2020)
  • K190965 — MyDay (April 29, 2019)
  • K181920 — Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens wi (December 11, 2018)
  • K160803 — Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens (July 13, 2016)
  • K133627 — AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS (December 23, 2013)
  • K131378 — SUS (STENFILCON A) CONTACT LENS (August 30, 2013)
  • K123202 — PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS (May 30, 2013)

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