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510(k) Premarket Notification

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Device Classification Name powered laser surgical instrument
510(k) NumberK031954
Device NameCOOLTOUCH INCORPORATED MODEL"CT3" ND:YAG SURGICAL LASER SYSTEMS
Applicant
NEW STAR LASERS, INC.
9085 foothills blvd.
roseville,  CA  95747
Contactdonald v johnson
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/01/2003
Decision Date 08/21/2003
Decision substantially equivalent (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Statement/Summary/Purged Status Summary only
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
 
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