• 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 biomicroscope, slit-lamp, ac-powered
510(k) Number K122418
Device Name IOLMASTER 500
Original Applicant
5160 hacienda drive
dublin,  CA  94568
Original Contact judith a brimacombe
Regulation Number886.1850
Classification Product Code
Date Received08/08/2012
Decision Date 04/12/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls