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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 K100019
Device Name PASCAL STREAMLINE PHOTOCOAGULATOR
Applicant
Optimedica Corporation
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Applicant Contact DARLENE CROCKETT-BILLING
Correspondent
Optimedica Corporation
155-A Moffett Park Dr.,
Suite 210
Sunnyvale,  CA  94089
Correspondent Contact DARLENE CROCKETT-BILLING
Regulation Number886.4390
Classification Product Code
HQF  
Date Received01/05/2010
Decision Date 05/04/2010
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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