Device Classification Name |
photocoagulator and accessories
|
510(k) Number |
K111493 |
Device Name |
NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI |
Applicant |
NIDEK CO., LTD. |
755 N. MATHILDA AVENUE |
SUITE 100 |
SUNNYVALE,
CA
94085
|
|
Applicant Contact |
MICHAEL J BILLIG |
Correspondent |
NIDEK CO., LTD. |
755 N. MATHILDA AVENUE |
SUITE 100 |
SUNNYVALE,
CA
94085
|
|
Correspondent Contact |
MICHAEL J BILLIG |
Regulation Number | 886.4690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 05/31/2011 |
Decision Date | 07/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|