Device Classification Name |
lenses, soft contact, daily wear
|
510(k) Number |
K200528 |
Device Name |
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism |
Applicant |
Bausch + Lomb, Incorporated |
1400 North Goodman Street |
Rochester,
NY
14609
|
|
Applicant Contact |
Barbara Klube-Falso |
Correspondent |
Bausch + Lomb, Incorporated |
1400 North Goodman Street |
Rochester,
NY
14609
|
|
Correspondent Contact |
Barbara Klube-Falso |
Regulation Number | 886.5925
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/02/2020 |
Decision Date | 06/02/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ophthalmic
|
510k Review Panel |
Ophthalmic
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT04158466
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|