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U.S. Department of Health and Human Services

Product Classification

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Device lacrimal stents and intubation sets
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.
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.
Target Area These devices are restricted to the nasal punctum and lacrimal ducts of the eye.
Review Panel Ophthalmic
Product CodeOKS
Premarket Review Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1)
Ophthalmic Devices (DHT1A)
Unclassified Reason Pre-Amendment
Submission Type 510(k)
Device Class Unclassified
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible