| Device Classification Name |
biomicroscope, slit-lamp, ac-powered
|
|---|
| 510(K) Number |
K122481 |
|---|
| Model |
LVI-1000, LVI-1001
|
| Device Name |
LIPIVIEW OCULAR SURFACE INTERFEROMETER |
|---|
| Applicant |
| TEARSCIENCE, INC. |
| 5151 mccrimmon parkway |
| suite 250 |
|
morrisville,
NC
27560
|
|
| Contact |
christy stevens |
| Regulation Number | 886.1850
|
|---|
| Classification Product Code |
|
|---|
| Subsequent Product Code |
|
|---|
| Date Received | 08/14/2012 |
|---|
| Decision Date | 12/31/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Ophthalmic
|
|---|
| Review Advisory Committee |
Ophthalmic
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
