Cleared Traditional

Ritleng?+ and Ritleng?+ PVP

K201892 · Fci (France Chirurgie Instrumentation) Sas · Ophthalmic

Mar 2021

Decision

246d

Days

—

Risk

About This 510(k) Submission

K201892 is an FDA 510(k) clearance for the Ritleng?+ and Ritleng?+ PVP, a Lacrimal Stents And Intubation Sets, submitted by Fci (France Chirurgie Instrumentation) Sas (Paris, FR). The FDA issued a Cleared decision on March 11, 2021, 246 days after receiving the submission on July 8, 2020. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K201892 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 08, 2020
Decision Date	March 11, 2021
Days to Decision	246 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.