Device Classification Name |
Photocoagulator And Accessories
|
510(k) Number |
K110228 |
Device Name |
NIDEK MULTICOLOR LASER PHOTOCOAGULATOR |
Applicant |
NIDEK INCORPORATED |
155-A MOFFETT PARK DRIVE |
SUITE 210 |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
KIT CARIQUITAN |
Correspondent |
NIDEK INCORPORATED |
155-A MOFFETT PARK DRIVE |
SUITE 210 |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
KIT CARIQUITAN |
Regulation Number | 886.4690
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 01/26/2011 |
Decision Date | 02/23/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|