Cleared Special

K170247 - Lacriflow CL

K170247 · Kaneka Pharma America, LLC · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
81d
Days
-
Risk

K170247 is an FDA 510(k) clearance for the Lacriflow CL. Classified as Lacrimal Stents And Intubation Sets (product code OKS).

Submitted by Kaneka Pharma America, LLC (New York, US). The FDA issued a Cleared decision on April 18, 2017 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Kaneka Pharma America, LLC devices

Submission Details

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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 110d · This submission: 81d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - OKS Lacrimal Stents And Intubation Sets

Devices cleared under the same product code (OKS) and FDA review panel - the closest regulatory comparables to K170247.
Ritleng®+ and Ritleng®+ PVP
K201892 · Fci (France Chirurgie Instrumentation) Sas · Mar 2021
LacriJet®
K201606 · Fci (France Chirurgie Instrumentation) Sas · Dec 2020
LACRICATH LACRIMAL DUCT CATHETER
K113867 · Quest Medical, Inc. · Oct 2012
STENTUBE LACRIMAL INTUBATION SET
K113118 · Quest Medical, Inc. · Jul 2012