Device Classification Name |
Lenses, Soft Contact, Daily Wear
|
510(k) Number |
K132715 |
Device Name |
BAUSCH + LOMB BIOTURE ONEDAY FOR PRESBYOPIA (NESOFILCON A) CONTACT LENS |
Applicant |
BAUSCH & LOMB INCORPORATED |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609
|
|
Applicant Contact |
JENNIFER KNICLEY |
Correspondent |
BAUSCH & LOMB INCORPORATED |
1400 NORTH GOODMAN ST. |
ROCHESTER,
NY
14609
|
|
Correspondent Contact |
JENNIFER KNICLEY |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/30/2013 |
Decision Date | 12/20/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|