| Device Type ID | 4440 |
| Device Name | Plug, Punctum |
| Review Panel | Ophthalmic |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Ophthalmic And Ear, Nose And Throat Devices (DOED) Intraocular And Corneal Implants Devices Branch (ICIB) |
| Submission Type | 510(k) |
| FDA Device Classification | Class Unclassified Medical Device |
| Product Code | LZU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 4440 |
| Device | Plug, Punctum |
| Product Code | LZU |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
KRISHNA IMPORTS INC DBA STEPHENS INSTRUMENTS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LACRIMEDICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
OASIS MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PARAGON BIOTECK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RIVERPOINT MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Lacrimedics Inc | III | Feb-10-2015 |