Device Classification Name |
Unit, Phacofragmentation
|
510(k) Number |
K120912 |
Device Name |
INFINITI(R) VISION SYSTEM |
Applicant |
ALCON MANUFACTURING, LTD. |
15800 ALTON PKWY. |
IRVINE,
CA
92618 -3818
|
|
Applicant Contact |
MARTIN A KAUFMAN |
Correspondent |
ALCON MANUFACTURING, LTD. |
15800 ALTON PKWY. |
IRVINE,
CA
92618 -3818
|
|
Correspondent Contact |
MARTIN A KAUFMAN |
Regulation Number | 886.4670
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 03/26/2012 |
Decision Date | 06/15/2012 |
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
|
|
|