Device Classification Name |
Eyelid Thermal Pulsation System
|
510(k) Number |
K200400 |
Device Name |
Systane iLux2 |
Applicant |
Tear Film Innovations, Inc. |
5924 Balfour Court, Suite 100 |
Carlsbad,
CA
92008
|
|
Applicant Contact |
Neal Hartman |
Correspondent |
Tear Film Innovations, Inc. |
5924 Balfour Court, Suite 100 |
Carlsbad,
CA
92008
|
|
Correspondent Contact |
Neal Hartman |
Regulation Number | 886.5200
|
Classification Product Code |
|
Date Received | 02/18/2020 |
Decision Date | 05/21/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|