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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratome, Water Jet
510(k) Number K991124
Device Name VISIJET HYDROKERATOME, MODEL 50
Applicant
Visijet, Inc.
18732 Saginaw
Irvine,  CA  92614
Applicant Contact JUDY F GORDON
Correspondent
Visijet, Inc.
18732 Saginaw
Irvine,  CA  92614
Correspondent Contact JUDY F GORDON
Regulation Number886.4370
Classification Product Code
MYD  
Date Received04/02/1999
Decision Date 10/20/2000
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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