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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 K072751
Device Name COOLTOUCH MODELS NS 160 AND LC215 COOLIPO
Applicant
New Star Lasers, Inc.
9085 Foothills Blvd.
Roseville,  CA  95747
Applicant Contact NATALIE R VOLLRATH
Correspondent
New Star Lasers, Inc.
9085 Foothills Blvd.
Roseville,  CA  95747
Correspondent Contact NATALIE R VOLLRATH
Regulation Number878.4810
Classification Product Code
GEX  
Date Received09/27/2007
Decision Date 01/02/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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