Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
510(k) Number |
K133132 |
Device Name |
OPTICAL BIOMETER AL-SCAN |
Applicant |
NIDEK CO., LTD. |
755 N. MATHILDA AVENUE |
SUITE 100 |
SUNNYVALE,
CA
94085
|
|
Applicant Contact |
DARLENE CROCKETT-BILLIG |
Correspondent |
NIDEK CO., LTD. |
755 N. MATHILDA AVENUE |
SUITE 100 |
SUNNYVALE,
CA
94085
|
|
Correspondent Contact |
DARLENE CROCKETT-BILLIG |
Regulation Number | 886.1850
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/30/2013 |
Decision Date | 06/11/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01729962
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|