• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name lenses, soft contact, daily wear
510(k) Number K113168
Device Name DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC
Original Applicant
CIBA VISION CORPORATION
11460 johns creek parkway
duluth,  GA  30097
Original Contact alicia m plesnarski
Regulation Number886.5925
Classification Product Code
LPL  
Subsequent Product Code
MVN  
Date Received10/27/2011
Decision Date 03/30/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Clinical Trials NCT01295905
Reviewed by Third Party No
Combination Product No
-
-