EV MONOCANALICULAR STENT (TM)
Device Facts
| Record ID | K883233 |
|---|---|
| Device Name | EV MONOCANALICULAR STENT (TM) |
| Applicant | Eagle Vision, Inc. |
| Product Code | OKS · OP |
| Decision Date | Aug 22, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Device Class | Class U |
Regulatory Classification
Identification
Lacrimal stents and intubations sets are intended to repair the lacrimal drainage system. Lacrimal stents and intubations sets are indicated for, but limited to, the treatment of epiphora in infants and adults; canalicular pathologies such as stenosis; obstruction or laceration; and conditions requiring dacryocystorhinostomy (conventional or laser); or imperforation of the nasolacrimal duct in an infant.
