Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K170718 |
Device Name |
Iridex TruFocus LIO Premiere |
Applicant |
Iridex Corporation |
1212 Terra Bella Avenue |
Mountain View,
CA
94043 -1824
|
|
Applicant Contact |
Gloria Dy |
Correspondent |
Iridex Corporation |
1212 Terra Bella Avenue |
Mountain View,
CA
94043 -1824
|
|
Correspondent Contact |
Gloria Dy |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/09/2017 |
Decision Date | 05/03/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|