Home / 510(k) Clearances / K113245

510(k) K113245

AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL by CooperVision, Inc. — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 2011
Date Received
November 2, 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

Other clearances by CooperVision, Inc.

  • K234127 — Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Con (January 25, 2024)
  • 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)
  • 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)

Other clearances for product code LPL

  • K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (March 13, 2026)
  • K254052 — DAILIES TOTAL1®; DAILIES TOTAL1® Multifocal (February 13, 2026)
  • K251683 — Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Bl (December 23, 2025)
  • K250364 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contac (October 7, 2025)
  • K244009 — Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for (September 25, 2025)
  • K251095 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses (September 17, 2025)
  • K251573 — VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens (September 10, 2025)
  • K242855 — P-CON (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) (July 30, 2025)
  • K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Peg (July 2, 2025)
  • K242056 — miacare (DELiGHT daily wear/ DELiGHT 1-day/ CONFiDENCE Color daily wear/CONFiDEN (April 17, 2025)