Device Classification Name |
ophthalmic femtosecond laser
|
510(k) Number |
K163551 |
Device Name |
LenSx Laser System |
Applicant |
Alcon Laboratories, Inc. |
20511 Lake Forest Dr |
Lake Forest,
CA
92630
|
|
Applicant Contact |
James Arganda |
Correspondent |
Alcon Laboratories, Inc. |
20511 Lake Forest Dr |
Lake Forest,
CA
92630
|
|
Correspondent Contact |
James Arganda |
Regulation Number | 886.4390
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 12/19/2016 |
Decision Date | 02/03/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|