Device Classification Name |
system, imaging, optical coherence tomography (oct)
|
510(k) Number |
K123369 |
Device Name |
ILUMIEN OPTIS |
Applicant |
LIGHTLAB IMAGING, INC. |
4 ROBBINS ROAD |
WESTFORD,
MA
01886
|
|
Applicant Contact |
JEFFREY ROBERTS |
Correspondent |
LIGHTLAB IMAGING, INC. |
4 ROBBINS ROAD |
WESTFORD,
MA
01886
|
|
Correspondent Contact |
JEFFREY ROBERTS |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 11/01/2012 |
Decision Date | 01/30/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|