K170247 is an FDA 510(k) clearance for the Lacriflow CL. This device is classified as a Lacrimal Stents And Intubation Sets.
Submitted by Kaneka Pharma America, LLC (New York, US). The FDA issued a Cleared decision on April 18, 2017, 81 days after receiving the submission on January 27, 2017.
This device falls under the Ophthalmic FDA review panel. 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..
| 510(k) Number | K170247 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 27, 2017 |
| Decision Date | April 18, 2017 |
| Days to Decision | 81 days |
| Submission Type | Special |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OKS - Lacrimal Stents And Intubation Sets |
| Device Class | - |
| Definition | 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. |