Device Classification Name |
unit, phacofragmentation
|
510(k) Number |
K162342 |
Device Name |
Stellaris Elite Vision Enhancement System |
Applicant |
Bausch + Lomb |
3365 Tree Ct. Industrial Blvd. |
St. Louis,
MO
63122
|
|
Applicant Contact |
Ken Nehmer |
Correspondent |
Bausch + Lomb |
3365 Tree Ct. Industrial Blvd. |
St. Louis,
MO
63122
|
|
Correspondent Contact |
Ken Nehmer |
Regulation Number | 886.4670
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/22/2016 |
Decision Date | 03/24/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|