# K170247: Lacriflow CL

- Pathway: 510(k) (Special)
- Applicant: Kaneka Pharma America, LLC
- Decided: Apr 18, 2017 after 81 days
- Product code: OKS (Lacrimal Stents And Intubation Sets)
- Device class: U
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K991238 (1999). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120886: Lacrifast, Hiroyasu Higuchi (2012) Summary page 5.

## Indications for use
The Lacriflow CL is indicated in treatments of epiphora in patients 12 months and older, in cases of: - Canalicular pathologies (stenosis, obstruction, lacerations), - During Dacryocystorhinostomy (conventional or laser), - Congenital nasolacrimal duct obstruction.

Source page: https://510kreport.com/device/K170247
Methodology: https://510kreport.com/methodology