# K201606: LacriJet®

- Pathway: 510(k) (Traditional)
- Applicant: Fci (France Chirurgie Instrumentation) Sas
- Decided: Dec 18, 2020 after 186 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 K061404 (2006). 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)
- K113536: Masterka 40 Masterka 35 Masterka 30, Fci Sas (France Chirurgie Instrumentation) (2012) Summary page 4.
- K883233: EV Monocanalicular Stent (TM), Eagle Vision, Inc. (1988) Summary page 4.

## Indications for use
LACRIJET® from 30 to 50 mm are indicated in the treatment of congenital lacrimal duct obstructions (stenosis of the valve of Hasner) in patients 12 months and older. LACRIJET® with small size (15/20 mm) are indicated in the repair of canalicular lacerations.

Source page: https://510kreport.com/device/K201606
Methodology: https://510kreport.com/methodology