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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name lasers for temporary increase of clear nail in patients with onychomycosis
510(k) Number K103338
Device Name COOLTOUCH
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
PDZ  
Subsequent Product Code
GEX  
Date Received11/15/2010
Decision Date 11/01/2011
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
Recalls CDRH Recalls
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