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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
Recalls CDRH Recalls
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