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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 K103540
Device Name PSORIA-LIGHT
Applicant
Psoria-Shield, Inc.
19404 Pine Valley Dr.
Odessa,  FL  33556
Applicant Contact WAYNE GLOVER
Correspondent
Psoria-Shield, Inc.
19404 Pine Valley Dr.
Odessa,  FL  33556
Correspondent Contact WAYNE GLOVER
Regulation Number878.4630
Classification Product Code
FTC  
Date Received12/02/2010
Decision Date 02/10/2011
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
Predetermined Change
Control Plan Authorized		 No
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