| Device Classification Name |
lenses, soft contact, daily wear
|
|---|
| 510(K) Number |
K122315 |
|---|
| Device Name |
FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC |
|---|
| Applicant |
| OCULUS PRIVATE LIMITED |
| 33 golden eagle lane |
|
littleton,
CO
80127
|
|
| Contact |
kevin walls |
| Regulation Number | 886.5925
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 08/06/2012 |
|---|
| Decision Date | 02/15/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Ophthalmic
|
|---|
| Review Advisory Committee |
Ophthalmic
|
|---|
| statement |
statement
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
