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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 K171488
Device Name PSLT for PASCAL Streamline
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  
Date Received05/22/2017
Decision Date 11/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Clinical Trials NCT02231515
Reviewed by Third Party No
Combination Product No
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