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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 K002347
Device Name COOLTOUCH II
Applicant
NEW STAR LASERS, INC.
11802 KEMPER RD.
AUBURN,  CA  95603
Applicant Contact DONALD V JOHNSON
Correspondent
NEW STAR LASERS, INC.
11802 KEMPER RD.
AUBURN,  CA  95603
Correspondent Contact DONALD V JOHNSON
Regulation Number878.4810
Classification Product Code
GEX  
Date Received08/02/2000
Decision Date 08/17/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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