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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Keratome, Ac-Powered
510(k) Number K990227
Device Name ULTRASHAPER KERATOME
Applicant
Lasersight Technologies, Inc.
3300 University Blvd.
Suite 140
Winter Park,  FL  32792
Applicant Contact MICHAEL P DAYTON
Correspondent
Lasersight Technologies, Inc.
3300 University Blvd.
Suite 140
Winter Park,  FL  32792
Correspondent Contact MICHAEL P DAYTON
Regulation Number886.4370
Classification Product Code
HNO  
Date Received01/25/1999
Decision Date 01/31/2000
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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