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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 K090097
Device Name LH-75T PHOTOTHERAPY SYSTEM
Applicant
Lerner Medical Devices, Inc.
1545 Sawtelle Blvd., Suite 36
Los Angeles,  CA  90025
Applicant Contact ZAFIRIOS GOURGOULIATOS
Correspondent
Lerner Medical Devices, Inc.
1545 Sawtelle Blvd., Suite 36
Los Angeles,  CA  90025
Correspondent Contact ZAFIRIOS GOURGOULIATOS
Regulation Number878.4630
Classification Product Code
FTC  
Date Received01/15/2009
Decision Date 02/26/2009
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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