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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Neodymium:Yag, Ophthalmic For Posterior Capsulotomy And Cutting Pupilla
510(k) Number K892058
Device Name ISL QC 2000
Applicant
Intelligent Surgical Lasers, Inc.
P.O. Box 85608
Rm. 2-105
San Diego,  CA  92138
Applicant Contact WILLIAM S KONOWITZ
Correspondent
Intelligent Surgical Lasers, Inc.
P.O. Box 85608
Rm. 2-105
San Diego,  CA  92138
Correspondent Contact WILLIAM S KONOWITZ
Regulation Number886.4392
Classification Product Code
LXS  
Date Received03/29/1989
Decision Date 06/15/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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