Cleared Traditional

K140290 - STOPLOSS JONES TUBE (FDA 510(k) Clearance)

K140290 · Ljt Surgical, Ltd. · Ophthalmic device
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Dec 2014
Decision
300d
Days
-
Risk

K140290 is an FDA 510(k) clearance for the STOPLOSS JONES TUBE. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Ljt Surgical, Ltd. (Chevy Chase, US). The FDA issued a Cleared decision on December 2, 2014 after a review of 300 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

View all Ljt Surgical, Ltd. devices

Submission Details

510(k) Number K140290 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
190d slower than avg
Panel avg: 110d · This submission: 300d
Pathway characteristics
Predicate-based equivalence.

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.