Device Classification Name |
system, imaging, optical coherence tomography (oct)
|
510(k) Number |
K152120 |
Device Name |
OPTIS Mobile System |
Applicant |
LIGHTLAB IMAGING, INC. |
4 ROBBINS ROAD |
WESTFORD,
MA
01866
|
|
Applicant Contact |
PADMINI SURAVARAM |
Correspondent |
LIGHTLAB IMAGING, INC. |
4 ROBBINS ROAD |
WESTFORD,
MA
01866
|
|
Correspondent Contact |
PADMINI SURAVARAM |
Regulation Number | 892.1560
|
Classification Product Code |
|
Date Received | 07/30/2015 |
Decision Date | 10/29/2015 |
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
|
|
|