DENOVOCLASSIFICATIONREQUESTFOR方案.PDFVIP

DE NOVO CLASSIFICATION REQUEST FOR ® TEARSCIENCE, INC. LIPIFLOW THERMAL PULSATION SYSTEM REGULATORY INFORMATION FDA identifies this generic type of device as: Eyelid Thermal Pulsation System. An eyelid thermal pulsation system is an electrically- powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids. NEW REGULATION NUMBER : 886.5200 CLASSIFICATION : II PRODUCT CODE: ORZ BACKGROUND ® DEVICE NAME : LIPIFLOW THERMAL PULSATION SYSTEM SUBMISSION NUMBER : K093937 DATE OF DE NOVO: AUGUST 6, 2010 CONTACT: TEARSCIENCE, INC . CHRISTY STEVENS, OD PHONE : (919) 459-4815 FAX : (919) 467-3300 EMAIL: CSTEVENS@TEARSCIENCE.COM REQUESTER’S RECOMMENDED CLASSIFICATION : CLASS II INDICATIONS FOR USE (IFU) The LipiFlow® System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. LIMITATIONS 1. Caution: Federal Law restricts this device to sale by or on the order of a physician. De Novo Summary (K093937) Page 1 of 8 PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS. DEVICE DESCRIPTION The physici