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U.S. Department of Health and Human Services

510(k) Premarket Notification

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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 (SE)
Classification Advisory Committee Ophthalmic
Review Advisory Committee Ophthalmic
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls