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 Number | 878.4630
|
Classification Product Code |
|
Date Received | 01/13/2004 |
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
|
|
|