Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K122220 |
Device Name |
ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S |
Applicant |
SOFLEX LIMITED |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Applicant Contact |
Kevin Walls |
Correspondent |
SOFLEX LIMITED |
33 Golden Eagle Lane |
Littleton,
CO
80127
|
|
Correspondent Contact |
Kevin Walls |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 07/25/2012 |
Decision Date | 03/19/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|