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510(k) K160803

Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens by CooperVision, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2016
Date Received
March 23, 2016
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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  • K220070 — MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vi (February 4, 2022)
  • 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)
  • 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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