• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name unit, phacofragmentation
510(k) Number K120912
Model TBD
Device Name INFINITI(R) VISION SYSTEM
Original Applicant
ALCON MANUFACTURING, LTD.
15800 alton pkwy.
irvine,  CA  92618 3818
Original Contact martin a kaufman
Regulation Number886.4670
Classification Product Code
HQC  
Subsequent Product Codes
HQR   KYB   MLZ  
Date Received03/26/2012
Decision Date 06/15/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-