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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 K024020
Device Name THERALIGHT UV120-2 UVA/UVB PHOTOTHERAPY SYSTEM
Applicant
Theralight, Inc.
2794 Loker Ave. W.,Suite 105
Carlsbad,  CA  92008 -6616
Applicant Contact KEVIN E DALY
Correspondent
Theralight, Inc.
2794 Loker Ave. W.,Suite 105
Carlsbad,  CA  92008 -6616
Correspondent Contact KEVIN E DALY
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/05/2002
Decision Date 01/17/2003
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
Predetermined Change
Control Plan Authorized		 No
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