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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 K040062
Device Name LEVIA PHOTOTHERAPY SYSTEM
Applicant
LERNER MEDICAL DEVICES, INC.
1545 SAWTELLE BLVD., SUITE 36
LOS ANGELES,  CA  90025
Applicant Contact ZAFIRIOS GOURGOULIATOS
Correspondent
ENTELA, INC.
3033 MADISON AVENUE, SE
GRAND RAPIDS,  MI  49548
Correspondent Contact N.E. DEVINE, JR.
Regulation Number878.4630
Classification Product Code
FTC  
Date Received01/13/2004
Decision Date 02/13/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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