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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light, Ultraviolet, Dermatological
510(k) Number K061589
Device Name SOLARC / SOLRX HANDHELD ULTRAVIOLET PHOTOTHERAPY LAMP UNIT FAMILY
Applicant
Solarc Systems, Inc.
12 Parker Ct.
Barrie, Ontario,  CA L4N 2A6
Applicant Contact BRUCE ELLIOTT
Correspondent
Solarc Systems, Inc.
12 Parker Ct.
Barrie, Ontario,  CA L4N 2A6
Correspondent Contact BRUCE ELLIOTT
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/08/2006
Decision Date 08/04/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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