Device Classification Name |
Device, Analysis, Anterior Segment
|
510(k) Number |
K152311 |
FOIA Releasable 510(k) |
K152311
|
Device Name |
Pentacam AXL |
Applicant |
OCULUS OPTIKGERATE GMBH |
MUNCHHOLZHAUSER STRASE 29 |
WETZLA,
DE
35582
|
|
Applicant Contact |
ECKHARD LOH |
Correspondent |
HOGAN LOVELLS US LLP |
555 THIRTEENTH STREET NW |
WASHINGTON,
DC
20016
|
|
Correspondent Contact |
RANDY PREBULA |
Regulation Number | 886.1850
|
Classification Product Code |
|
Date Received | 08/14/2015 |
Decision Date | 01/20/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|