Device Classification Name |
Eyelid Thermal Pulsation System
|
510(k) Number |
K172645 |
Device Name |
iLux Instrument, iLux Disposable |
Applicant |
Tear Film Innovations, Inc. |
12625 High Bluff Drive, Suite 107 |
San Diego,
CA
92130
|
|
Applicant Contact |
John Slate |
Correspondent |
Tear Film Innovations, Inc. |
12625 High Bluff Drive, Suite 107 |
San Diego,
CA
92130
|
|
Correspondent Contact |
John Slate |
Regulation Number | 886.5200
|
Classification Product Code |
|
Date Received | 09/01/2017 |
Decision Date | 12/26/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|