Cleared Traditional

K201606 - LacriJet?
(FDA 510(k) Clearance)

K201606 · Fci (France Chirurgie Instrumentation) Sas · Ophthalmic
Dec 2020
Decision
186d
Days
—
Risk

K201606 is an FDA 510(k) clearance for the LacriJet?, a Lacrimal Stents And Intubation Sets, submitted by Fci (France Chirurgie Instrumentation) Sas (Paris, FR). The FDA issued a Cleared decision on December 18, 2020, 186 days after receiving the submission on June 15, 2020. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number K201606 FDA.gov
FDA Decision Cleared SESE
Date Received June 15, 2020
Decision Date December 18, 2020
Days to Decision 186 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF

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.