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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Ophthalmic
510(k) Number K123542
FOIA Releasable 510(k) K123542
Device Name PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
Applicant
Topcon Medical Laser Systems, Inc.
2800 Pleasant Hill Rd.,
Suite 175
Pleasant Hill,  CA  94553
Applicant Contact PAMELA M BUCKMAN
Correspondent
Topcon Medical Laser Systems, Inc.
2800 Pleasant Hill Rd.,
Suite 175
Pleasant Hill,  CA  94553
Correspondent Contact PAMELA M BUCKMAN
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received11/19/2012
Decision Date 05/15/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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