Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K133242 |
Device Name |
STELLARIS VISION ENHANCEMENT SYSTEM |
Applicant |
BAUSCH & LOMB |
3365 TREE COURT INDUSTRIAL BLV |
ST LOUIS,
MO
63122
|
|
Applicant Contact |
TIMOTHY W CAPEHART |
Correspondent |
BAUSCH & LOMB |
3365 TREE COURT INDUSTRIAL BLV |
ST LOUIS,
MO
63122
|
|
Correspondent Contact |
TIMOTHY W CAPEHART |
Regulation Number | 886.4670
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 10/21/2013 |
Decision Date | 02/14/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|