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510(k) K133176

AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL by Ciba Vision Corporation — Product Code LPL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 29, 2014
Date Received
October 17, 2013
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

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  • K062262 — CIBA VISION (SIFILCON A) SPHERICAL, TORIC, MULTIFOCAL AND MULTIFOCAL TORIC DESIG (November 14, 2006)
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  • K050250 — AQUIFY MULTIPURPOSE SOLUTION (August 10, 2005)
  • K050065 — FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES (May 27, 2005)
  • K050213 — FRESHLOOK ONE-DAY COLOR CONTACT LENS (March 28, 2005)

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