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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Laser Surgical Instrument
510(k) Number K012982
Device Name COOLTOUCH VARIZOOM
Applicant
New Star Lasers, Inc.
9085 Foothills Blvd.
Roseville,  CA  95747
Applicant Contact DONALD V JOHNSON
Correspondent
New Star Lasers, Inc.
9085 Foothills Blvd.
Roseville,  CA  95747
Correspondent Contact DONALD V JOHNSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/05/2001
Decision Date 10/02/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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