# K120886: Lacrifast

- Pathway: 510(k) (Traditional)
- Applicant: Hiroyasu Higuchi
- Decided: Dec 17, 2012 after 269 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: 1 generation back to K991238 (1999). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991238: Fci Crawford Probe Intubation Sets, Fci Ophthalmics, Inc. (1999) Summary page 2.
- K041869: Self Retaining Bicanaliculus Intubation Set, Fci Ophthalmics, Inc. (2004) Summary page 2.

## Most influential descendants
- K170247: Lacriflow CL (2017), 0 descendants of its own
- K161373: Nunchaku (2016), 0 descendants of its own

## Indications for use
The LACRIFLOW 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/K120886
Methodology: https://510kreport.com/methodology