Device Classification Name |
light, ultraviolet, dermatological
|
510(k) Number |
K011197 |
Device Name |
DERMACLEAR UV-B PHOTOTHERAPY SYSTEM |
Applicant |
LUMENIS |
1249 QUARRY LN. |
SUITE 100 |
PLEASANTON,
CA
94566 -3403
|
|
Applicant Contact |
C. ROBERT PAYNE JR. |
Correspondent |
LUMENIS |
1249 QUARRY LN. |
SUITE 100 |
PLEASANTON,
CA
94566 -3403
|
|
Correspondent Contact |
C. ROBERT PAYNE JR. |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 04/19/2001 |
Decision Date | 12/14/2001 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|