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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 K061295
Device Name VERSACLEAR SKIN THERAPY SYSTEM, MODEL 100
Applicant
Theralight, Inc.
2794 Loker Ave. W.,Suite 105
Carlsbad,  CA  92010
Applicant Contact KEVIN E DALY
Correspondent
Theralight, Inc.
2794 Loker Ave. W.,Suite 105
Carlsbad,  CA  92010
Correspondent Contact KEVIN E DALY
Regulation Number878.4630
Classification Product Code
FTC  
Date Received05/09/2006
Decision Date 05/25/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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