Device Classification Name |
lamp, infrared, non heating
|
510(k) Number |
K903660 |
Device Name |
DERMALIGHT PSORACOMB |
Applicant |
SOLITEC GMBH |
FRAUNHOFERSTRASSE 5 |
PLANEGG,
DE
D-82152
|
|
Applicant Contact |
SCHIMD |
Correspondent |
SOLITEC GMBH |
FRAUNHOFERSTRASSE 5 |
PLANEGG,
DE
D-82152
|
|
Correspondent Contact |
SCHIMD |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 08/10/1990 |
Decision Date | 07/17/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|