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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 K180402
Device Name PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
Applicant
Topcon Medical Laser Systems, Inc.
606 Enterprise Ct.
Livermore,  CA  94550
Applicant Contact Sweta Srivastava
Correspondent
Topcon Medical Laser Systems, Inc.
606 Enterprise Ct.
Livermore,  CA  94550
Correspondent Contact Sweta Srivastava
Regulation Number886.4390
Classification Product Code
HQF  
Subsequent Product Code
GEX  
Date Received02/14/2018
Decision Date 05/25/2018
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
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