Cleared Traditional

MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE

K061404 · Fci Ophthalmics, Inc. · Ophthalmic

Aug 2006

Decision

80d

Days

—

Risk

About This 510(k) Submission

K061404 is an FDA 510(k) clearance for the MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE, a Lacrimal Stents And Intubation Sets, submitted by Fci Ophthalmics, Inc. (Centercille, US). The FDA issued a Cleared decision on August 7, 2006, 80 days after receiving the submission on May 19, 2006. This device falls under the Ophthalmic review panel.

Submission Details

510(k) Number	K061404 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 19, 2006
Decision Date	August 07, 2006
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Statement

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.