Submission Details
| 510(k) Number | K170247 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
Lacriflow CL
Apr 2017
Decision
81d
Days
—
Risk
About This 510(k) Submission
K170247 is an FDA 510(k) clearance for the Lacriflow CL, 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 review panel.
Device Classification
| 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. |
Manufacturer
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