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510(k) K202036

Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal by Alcon Laboratories, Inc. — Product Code MVN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 21, 2020
Date Received
July 23, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lens, Contact, (Disposable)
Device Class
Class II
Regulation Number
886.5925
Review Panel
OP
Submission Type

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  • K230785 — Precision1, Precision1 for Astigmatism (April 20, 2023)

Other clearances for product code MVN

  • K202448 — DAILIES AquaComfort Plus (DACP) / DACP FreshTech / DACP Toric / DACP Multifocal (September 22, 2020)
  • K150630 — Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily (June 15, 2015)
  • K143190 — Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens (January 16, 2015)
  • K130331 — SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT (July 26, 2013)
  • K112192 — NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS (October 25, 2011)
  • K080632 — CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS (October 15, 2008)
  • K080755 — SOFLENS DAILY DISPOSABLE TORIC (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (June 10, 2008)
  • K073060 — CALAVIEW (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR (November 29, 2007)
  • K061948 — PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS (November 22, 2006)
  • K061157 — SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS (June 22, 2006)