Device Classification Name |
Tonometer, Ac-Powered
|
510(k) Number |
K143086 |
Device Name |
VX120 Ophthalmic Diagnostic Device |
Applicant |
LUNEAU SAS |
1 avenue de Malaguet |
Prunay le Gillon,
FR
28360
|
|
Applicant Contact |
Isabelle Durand |
Correspondent |
LUNEAU SAS |
1 avenue de Malaguet |
Prunay le Gillon,
FR
28360
|
|
Correspondent Contact |
Isabelle Durand |
Regulation Number | 886.1930
|
Classification Product Code |
|
Date Received | 10/27/2014 |
Decision Date | 06/01/2015 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|