lioli™ IOL Delivery System Receives FDA 510(k) Clearance
Director, Sales & Marketing
Billerica, MA – April 9, 2015 – AST Products, Inc. has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its lioli™ IOL Delivery System to be sold in the United States.
The lioli™ IOL Delivery System is a single-use, sterile device intended to insert a one-piece foldable intraocular lens (IOL) into the human eye through a surgical procedure. The system provides a tubular pathway for lens implantation through an incision. The lioli™ IOL Delivery System is used only for the insertion of IOL models validated for use with this device as indicated in the IOL approved labeling. The set consists of a single-use, sterile syringe injector with a silicone tip and a single-use, sterile LubriMATRIX™-treated cartridge. The tip of the plunger, housed in the injector, is covered by a silicone cushion that provides a good contact to the lens to ensure a smooth delivery. This system is packaged in sets of 10, and is available in a range of models.
About AST Products, Inc.
AST Products, Inc. develops and manufactures medical devices and environmentally friendly surface modification solutions for a range of industries. The Company offers coatings for medical devices with supporting Device Master Files and contract coating services to facilitate customers’ product development and clinical trials. AST also provides specially engineered plasma reactors and contact angle analysis equipment.
For more information about AST Products and lioli™ visit www.lioli.us or call 978-667-4500.
lioli™ and LubriMATRIX™ are trademarks of AST Products, Inc.