Device Classification Name |
System, Imaging, Optical Coherence Tomography (Oct)
|
510(k) Number |
K160878 |
Device Name |
OPTIS Metallic Stent Optimization E.4 SW |
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 | 03/30/2016 |
Decision Date | 06/29/2016 |
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
|
|
|