OKS — Lacrimal Stents And Intubation Sets

Class U Implant

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.

Review Panel

OP

Submission Type

1

Target Area

These devices are restricted to the nasal punctum and lacrimal ducts of the eye.

Physical State

A stent is a small tube generally made of silicone that is placed at the point of constriction to open it up. The intubation set is composed of a balloon and catheter composed of silicone.

Technical Method

The nasal punctum is probed with a fine stainless steel probe to determine the patency of the opening and adjoining lacrimal duct. This procedure is known as dilation and then maybe followed by sterile saline irrigation to test for lower patency of the lacrimal duct. In some cases, dilation and irrigation alone are not sufficient. In those cases, a balloon and cathether composed of silicone is inserted into the punctum and then into the lacrimal duct to keep the nasolacrimal duct open thereby facilitating the drainage of tear fluid from the eye.

FDA Authorisations (31)

Device Name K-Number
Ritleng®+ and Ritleng®+ PVP K201892
LacriJet® K201606
Lacriflow CL K170247
Nunchaku K161373
Oasis Lacrimal Intubation Set K160710
DacryoCATH K142914
STOPLOSS JONES TUBE K140290
SELF-RETAINING BICANALICULUS INTUBATON SET II K130375
OPHTACATH KIT K123831
LACRIFAST K120886
DCS LACRIMAL STENT K113316
LACRICATH LACRIMAL DUCT CATHETER K113867
DACRYOCATH K113508
CRAWFORD BIOCANALICULUS INTUBATION K121142
MASTERKA 40 MASTERKA 35 MASTERKA 30 K113536
STENTUBE LACRIMAL INTUBATION SET K113118
MONO-CRAWFORD NASO-LACRIMAL INTUBATION DEVICE K061404
SELF RETAINING BICANALICULUS INTUBATION SET K041869
BECKER TRANSNASAL LACRIMAL (INTUBATION SETS) K023758
MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS K030353
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