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510(k) K133627

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2013
Date Received
November 26, 2013
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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  • 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)
  • K131378 — SUS (STENFILCON A) CONTACT LENS (August 30, 2013)
  • K123202 — PROCLEAR (OMAFILCON A) SOFT HYDROPHILIC) CONTACT LENS (May 30, 2013)

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