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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Laser, Comb, Hair
510(k) Number K132646
Device Name SUNETICS CLINICAL BIO-STIMULATION LASER
Applicant
Sunetics International Marketing Group, LLC
892 Steger Towne Rd. #44
Rockwall,  TX  75032
Applicant Contact JOHN CARULLO
Correspondent
Sunetics International Marketing Group, LLC
892 Steger Towne Rd. #44
Rockwall,  TX  75032
Correspondent Contact JOHN CARULLO
Regulation Number890.5500
Classification Product Code
OAP  
Subsequent Product Code
NHN  
Date Received08/26/2013
Decision Date 12/20/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
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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