Submission Details
| 510(k) Number | K140290 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 05, 2014 |
| Decision Date | December 02, 2014 |
| Days to Decision | 300 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
STOPLOSS JONES TUBE
Dec 2014
Decision
300d
Days
—
Risk
About This 510(k) Submission
K140290 is an FDA 510(k) clearance for the STOPLOSS JONES TUBE, a Lacrimal Stents And Intubation Sets, submitted by Ljt Surgical, Ltd. (Chevy Chase, US). The FDA issued a Cleared decision on December 2, 2014, 300 days after receiving the submission on February 5, 2014. 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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