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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 K091568
Device Name LH-75 PHOTOTHERAPY SYSTEM
Applicant
LERNER MEDICAL DEVICES, INC.
1545 SAWTELLE BLVD., SUITE 36
LOS ANGELES,  CA  90025
Applicant Contact ZAFIRIOS F GOURGOULIATOS
Correspondent
LERNER MEDICAL DEVICES, INC.
1545 SAWTELLE BLVD., SUITE 36
LOS ANGELES,  CA  90025
Correspondent Contact ZAFIRIOS F GOURGOULIATOS
Regulation Number878.4630
Classification Product Code
FTC  
Date Received06/02/2009
Decision Date 11/05/2009
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
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