Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number |
K120756 |
Device Name |
LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE |
Applicant |
THE LAGADO CORP. |
218 E. COMMERCIAL BLVD |
STE # 201-Q |
LAUDERDALE BY THE SEA,
FL
33308
|
|
Applicant Contact |
ELLEN BEUCLER |
Correspondent |
THE LAGADO CORP. |
218 E. COMMERCIAL BLVD |
STE # 201-Q |
LAUDERDALE BY THE SEA,
FL
33308
|
|
Correspondent Contact |
ELLEN BEUCLER |
Regulation Number | 886.5925
|
Classification Product Code |
|
Date Received | 03/13/2012 |
Decision Date | 05/13/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT01735045
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|