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510(k) K113759

AVAIRA (ENFILCON A) CONTACT LENS by CooperVision, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 3, 2012
Date Received
December 21, 2011
Clearance Type
Special
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

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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)
  • K191763 — MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) M (March 23, 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)

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