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The TearCare MGX System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.

The TearCare MGX System is designed to deliver controlled, precise heat to the tarsal plates and underlying meibomian glands of the eyelids for 15 minutes, followed by an optional warming hold time of up to 10 minutes to allow for manual expression. The TearCare MGX System is comprised of a reusable SmartHub, SmartCable, Charging Nest and charging adapter, and single use SmartLids. The TearCare MGX System is operated by an eye care practitioner, who affixes the SmartLids to the patient's eyelids, connects the SmartLids to the SmartHub with the SmartCable, and initiates the therapy session on the SmartHub. In the same manner as the predicate device, the system increases the temperature from the lowest warmth setting (41°C) to the highest warmth setting (45°C) when the therapy starts. The SmartHub controls the temperature until the 15-minutes of therapy are complete, at which time the system visually and audibly signals the end of therapy. At the end of the 15-minute core therapy, the TearCare MGX System transitions to an optional Warming Hold Time (WHT) that may last up to a maximum of 10 minutes. WHT holds the temperature at the lowest warmth setting (Warmth setting 1 and temperature set point of 41°C) allowing the eye care practitioner to individually express each eyelid while the lids are warm. To complete the TearCare MGX procedure, the eye care practitioner removes the SmartLid devices one at a time from the patient, then uses the separately available meibomian gland expression forceps (Clearance Assistant) to manually express the meibomian glands immediately following the eyelid heat therapy. Heat is discontinued once the SmartLid is removed prior to expression, at the end of the optional 10-minute WHT, or at any time the eye care practitioner utilizes the SmartHub control to interrupt (pause or stop) treatment. The subject TearCare MGX System is technologically the same as the predicate TearCare MGX System cleared under 510(k) K231084. Notably, there are no changes to the system impacting thermal exposure and limits regarding temperature control and regulation. The subject device of this submission proposes changes to the TearCare MGX System that impact the Instructions for Use (IFU), rather than a device technological change. The procedural instructions for use are updated with additional instruction for the application of the SmartLids including an earpiece fitment check to assess whether the ear loop requires further support.

The Tixel i is indicated for the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD).

The Tixel i is intended to deliver heat and pressure to the eyelids of patients with evaporative dry eye disease (DED) due to meibomian gland dysfunction (MGD). The Tixel i is comprised of a Console, which is connected via an umbilical tube to an applicator, referred to as "Handpiece." The Handpiece includes a therapeutic element, the "Tip," fixated on its distal end. A clear polycarbonate illuminated Distance Gauge, mounted on the distal end of the Handpiece, covers the Tip and allows proper and safe positioning of the Handpiece on the skin prior to performing a treatment pulse. The Distance Gauge is removed only when the Tip is being cleaned. The Tip is comprised of a gold-plated copper base and a thin-walled titanium alloy cover. The active surface of the Tip consists of an array of 24 (6×4) square-based pyramids, evenly spaced. The pyramids have a blunt apex to allow effective heat transfer and prevent any risk of mechanical puncturing of the skin. The backplane of the Tip attaches to a ceramic heater that maintains a constant temperature during operation. During a Tixel i procedure, an Aestek plastic ocular shield (Oculo-Plastik, Inc.) is to be inserted under the eyelids on the ocular surface to protect the eye during the procedure.

The TearCare MGX™ System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.

The TearCare MGX™ System is a powered device intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD). The TearCare MGX™ System is comprised of a TearCare SmartLids" device (PN 07064) and a TearCare System Kit (PN 06985), containing the TearCare SmartHub™ (PN 07066), SmartCable (PN 06998), Charging Nest (PN 07067), and IFU (PN 06988). The TearCare MGX™ System warms the eyelid(s) by heating the SmartLids to a maximum set point of 45°C. Heat is applied to the external or cutaneous surface of the eyelids via the adherent, disposable SmartLids that are powered by the SmartHub. The TearCare MGX™ System can warm the eyelids of one or both eyes at a time. A medical grade silicone adhesive on the SmartLid device surface physically and thermally couples the devices to the external (cutaneous) surface of the eyelids. The SmartHub includes a device port for SmartLid device attachment via a SmartCable. Additionally, the SmartHub includes an intuitive touchscreen interface, temperature control processor, and a rechargeable battery. The operator affixes the devices to the patient's eyelids to initiate a treatment session and may adjust the system warmth level during a session. After completion of the core thermal cycle, an extended warming time will automatically begin and stay active for up to 10 minutes at a set target temperature of 41°C that is not permitted to not exceed 43°C. The SmartLid devices are disposable and are not intended to contact the cornea or conjunctival surfaces of the eye. The system automatically and gradually increases the temperature over 2-3 minutes until it reaches the target range of 41-45°C to melt the meibum blocking the meibomian glands. The core thermal cycle lasts 15 minutes, followed by an optional extended warming time which may last up to an additional 10 minutes. After TearCare MGX treatment the eye care professional then uses a separately available Clearance Assistant™ to express the meibomian glands manually immediately following the eyelid heat treatment. The separately packaged sterile, single-use Clearance Assistant instrument is available from Sight Sciences and used in conjunction with the TearCare product. The Clearance Assistant instrument is a Class I, 510(k) exempt, meibomian gland expressor (Classification Product Code HNS, Regulation Number 886.4350). Safety and effectiveness of the TearCare MGX System has not been established when used in conjunction with any other meibomian gland expressor. Effectiveness of the TearCare MGX System has not been established without manual meibomian gland expression.

The TearCare® System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.

To use the TearCare System, the flexible SmartLids are applied to the external surface of the upper and lower eyelids of the right and left eye of the patient. The SmartLids are then connected to the SmartHub. When the SmartHub is turned on and the eye care professional initiates the procedure, the TearCare System begins delivering heat to the eyelids. The system automatically and gradually increases the temperature over 2-3 minutes until it reaches the target range of 41-45°C to melt the meibum blocking the meibomian gland orifices. A complete TearCare session lasts 15 minutes. After TearCare treatment the eye care professional then uses a separately available Clearance Assistant™ to express the meibomian glands manually immediately following the eyelid heat treatment. The separately packaged sterile, single-use Clearance Assistant instrument is available from Sight Sciences and used in conjunction with the TearCare product. The Clearance Assistant instrument is a Class I, 510(k) exempt, meibomian gland expressor (Classification Product Code HNS, Regulation Number 886.4350). Safety and effectiveness of the TearCare System has not been established when used in conjunction with any other meibomian gland expressor. Effectiveness of the TearCare System has not been established when used without manual meibomian gland expression. The TearCare System is comprised of the following key components and accessories: - . SmartHub – a reusable component that incorporates hardware and software to power the SmartLids during treatment. The SmartHub has 5 temperature set points (ranging from 41 to 45°C), which allow the user to manually adjust the temperature up or down to a level that is comfortable for the patient. The SmartHub is powered by an internal lithium-ion battery and has an intuitive 4-function, 3-button interface which provides the user the status and control of treatment initiation, treatment temperature setting, remaining treatment duration, and treatment termination. - . Charging Nest - a reusable plastic desktop cradle that holds one SmartHub in order to recharge the SmartHub battery. - Charging Adapter and Wall Plug - a reusable AC/DC wall-mount adapter that accommodates 80-264 VAC input voltage and provides 9.0 VDC output voltage to the SmartHub through the Charging Nest. - SmartLids – a single use component of the TearCare System that is designed to conform to the upper and lower eyelid. They contain flexible circuits, sensors and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical grade adhesive on the skin-facing surface of the SmartLids allow them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. Each SmartLid is connected to the SmartHub by a cable integrated into the SmartLid. The integrated cable is four feet in length.

The Systane iLux2 is indicated for the application of localized heat and pressure therapy in adult patients with Melbonian Gland Dysfunction (MGD), which is associated with evaporative dry eye, and to capture/store digital images and video of the meibomian glands.

The Subject Device is indicated for the application of localized heat and pressure therapy in adult patients with Meibomian Gland Dysfunction (MGD), which is associated with evaporative dry eye. The device can capture images and videos of the eyelid margin and meibomian glands. These images can be use in meibography (i.e., visual morphology of meibomian glands). In treatment mode, light-based heat is used to warm the eyelid tissue to a target range of 38-44 ℃ to melt the meibum blocking the gland orifices. The Eye Care Professionals (ECP) can apply compression to the eyelid to express the meibum through the orifices. At all times, the amount of the heat and pressure applied is under direct control of the ECP who monitors the response of the glands and the comfort of the patient. The inner eyelid temperature is displayed during the treatment process. The source of heating is lime-green and IR optical radiation produced by LEDs incorporated in the Instrument. Images and video can be captured during treatment. In meibography mode, infrared (IR) light is used in the visualization of meibomian gland morphology. Images can be captured with IR or white light. Video is captured only with white light. The Subject Device consists of the following: - Reusable, Hand-Held Instrument Incorporates hardware, software, and . mechanics to facilitate treatment and imaging. The Instrument incorporates an LCD touchscreen user interface that is used to view the eyelid margin as well as provides instructions to the ECP during use. Selections can be made through the user interface and images/video can be viewed. The Instrument is powered by a rechargeable lithium ion battery. - Docking Station Is used to charge the Instrument's internal battery and transfer . images/video to an external monitor or PC. - . AC Power Supply - Transfer electricity for the AC electrical outlet to the Docking Station. - . Photography Tip (Photo Tip) - Is reusable, up to a specified number of attachments, and when coupled with the Instrument it is used to capture images and video. There is electronics in the Photo Tip that interfaces with the Instrument. The Photo Tip is positioned on the cheek bone or eyebrow. The patient contacting material is biocompatible. - . Smart Tip Patient Interface (Smart Tip) - Is sterile and single-use that when coupled with the Instrument treatment can be provided. There is electronics in the Smart Tip that interfaces with the Instrument. A feature of the Smart Tip is positioned behind the eyelid during the treatment process. The patient contacting material is biocompatible. - USB & HMDI Cable Attaches Docking Station to external monitor/PC. .

The LipiFlow® Thermal Pulsation 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 eve or lipid deficiency dry eve.

The LipiFlow® Thermal Pulsation System is used by a physician in an in-office procedure for patients with chronic cystic conditions of the eyelids to provide controlled heat to the inner eyelid surface, close to the location of the meibomian glands, and intermittent pressure to the outer eyelid to facilitate release of lipid from the cystic meibomian glands. The LipiFlow® System is comprised of a physician interface (Control component labeled as "Console") and a patient interface (Disposable component labeled as "Activator II"). The Console provides the electrical power, user interface, treatment monitoring, treatment control and safeguard circuitry used for controlling the heat and pressure applied to the patient's eyelids with the Activator II Disposable. This 510(k) submission is for modification of the proposed Activator II Disposable (Model LFD-2100) and labeling changes to the predicate Activator II (Model LFD-2000). The proposed devices have the same intended use, indications for use and fundamental scientific technology as the legally marketed predicate device. The proposed Activator II Model (LFD-2100) is the same as the predicate Activator II Models (LFD-2000) except for the following: - . Eye Cup Assembly Redesign: the Activator II eye cup, which consists of the bladder and substrate, will be redesigned to allow the eye cup to be manufactured as a single versus seven-piece molded bladder assembly while still attaching to the lid warmer in the same location. - Back Surface Overmold Redesign: the back surface overmold of the lid warmer will be ● redesigned to accommodate the modified Single Piece Eye Cup. The design change will be limited to the removal of the t-extrusion in the Z-direction used to hold the original Eye Cup in position. - The material for the non-patient contact bladder substrate will be changed from Valox (PBT) to polycarbonate. The labeling for the predicate Activator II Model (LFD-2000) will also be updated to replace special storage and handling conditions with the statement: "Store at room temperature". Compared to the predicate Activator II Model, the patient interface portion of the proposed Activator II Model is identical in patient-contact materials, electrical safety, packaging, sterility, shelf-life, method of preventing re-use, and temperature and pressure performance and safety. The proposed Activator II Model (LFD-2100) will remain fully backwards compatible with the current LipiFlow Console and Semi-permanent Cable. There are no changes to the Console and Cable from the predicate device.

The iLux System is indicated for the application of localized heat and pressure therapy in adult patients with chronic diseases of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye.

The iLux System is a medical device intended for use by Licensed Eye Care Professionals (ECP) to apply localized heat and pressure therapy to adult patients' lower and/or upper eyelids. The il.ux System consists of a hand-held Instrument coupled to a single-use sterile Disposable component that is positioned behind the eyelid. The iLux System allows the ECP to view the eyelid margin through a magnifier, then warm the eyelid tissue to a target range of 40 to 42 °C to melt the meibum blocking the gland orifices and then apply compression to the eyelid to express the melted meibum through the orifices. The inner eyelid temperature and the amount of force applied to the eyelid are both displayed on the Instrument allowing the clinician to titrate the ideal amount of heating and compression to optimize unclogging of the blocked glands. The Disposable is a sterile, single-use component that is attached to the iLux Instrument. It includes all parts intended to contact the patient's eyelid. The iLux Instrument is a handheld device that allows the ECP to view, heat, and compress the portion of the eyelid that is in contact with the Disposable. The source of heating is lime-green and infrared optical radiation produced by LEDs in the Instrument. The ilux Instrument is powered by a rechargeable lithium ion battery. The software Level of Concern is Moderate. Ancillary accessories include the charging stand with AC power supply.

The LipiFlow® Thermal Pulsation 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.

The LipiFlow® Thermal Pulsation System is used by a physician in an in-office procedure for patients with chronic cystic conditions of the eyelids to provide controlled heat to the inner eyelid surface, close to the location of the meibomian glands, and intermittent pressure to the outer eyelid to facilitate release of lipid from the cystic meibomian glands. The LipiFlow® System is comprised of a physician interface (Control component) and a patient interface (Disposable component). The Control component (labeled as Console) provides the electrical power, user interface, treatment monitoring, treatment control and safeguard circuitry used for controlling the heat and pressure applied to the patient's eyelids by the Disposable component (labeled as Activator). This 510(k) submission is for the device modification of new model of the Disposable component (labeled Activator II, Model LFD-2000), a new semi-permanent Cable (Model CBL-2000), and a hardware and software update to the Control component (labeled as Console, Model LFTP-1000). The modified LipiFlow® System has the same intended use, indications for use and fundamental scientific technology as the legally marketed predicate device.

The LipiFlow Thermal Pulsation 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.

The LipiFlow Thermal Pulsation System is used by a physician in an in-office procedure for patients with chronic cystic conditions of the eyelids to provide controlled heat to the inner eyelid surface, close to the location of the meibomian glands, and intermittent pressure to the outer eyelid to facilitate release of lipid from the cystic neibomian glands. The LipiFlow System is comprised of a physician interface (Control component) and a patient interface (Disposable component). The Console (Control component) provides the electrical power, user interface, treatment monitoring, treatment control and safeguard circuitry used for controlling the heat and pressure applied to the patient's eyelids by the Activators (Disposable component). No changes to the Console are proposed in this 510(k). The Activator (Disposable) is a sterile; single-use. biocompatible eyepiece made of polycarbonate and silicone and is inserted around the patient's eyelids. The Activator (Disposable) consists of a combined eye cup and lid warmer with attached tubing and wiring that connect to the Console with a connector. There are two models of the Activator (Disposable). Except for the addition of a memory device, Activator (Disposable) Models LFD-1000 (cleared under K093937) and LFD-1100 (modified under design controls) are equivalent with no difference in device performance, safety or effectiveness. This 510(k) submission is for a device modification of new materials for the LipiFlow Activator (Disposable). The proposed changes to the Activator (Disposable) are to provide a second source for the raw materials used in the eyecup bladder (diaphragm), lid warnier glue and heater components to facilitate manufacturing. The model numbers of the Activator (Disposable) will not change as a result of this change. The LipiFlow Activator (Disposable) with the new second source materials has the same intended use and same fundamental scientific technology as the predicate cleared device (LipiFlow® Activator (Disposable) with cleared materials, as described in K093937 and K.I. 2704). Accordingly, this 510(k) submission for a design change to use second source new materials in the Activator (Disposable) applies to both model numbers (LFD-1000 and LFD-1100) of the Disposable component.

The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic condictions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

The LipiFlow® Thermal Pulsation System is used by a physician in an in-office procedure for patients with chronic cystic conditions of the eyelids to provide controlled heat to the inner eyelid surface, close to the location of the meibomian glands, and intermittent prossure the outer eyelid to facilitate release of lipid from the cystic meibomian glands. The LipiFlow System is comprised of physician interface (Control component) and a patient interface (Disposable component). There are two models of the Control component: Model LFH-1000, Handheid Control System (HCS) and Model LFTP-1000, Console. The Console is a rhange in design from the HCS predicate device model. The LipiFlow® Console was developed fring the same treatment control technology as in the LipiFlow® FICS with enhancements in the user interface and power source. Both the Console and HCS work with the same Disposable component (Model LFD-1000), now labeled as Activator (Disposable). The Activator (Disposable) is a sterile, single-use, biocompatible eyepiece made of polycarbonate and silicone and is inserted around the patient's cyelids. The Activator (Disposable) consists of a combined eye cup and lid warmer with attached tubing and wiring that connect to the Console with a connector. The Console is an AC-powered, bench-top device used by the physician to control the application of heat and pressure to the patient's eyelids. The Console consists of a Windows XP embedded computer subsystem with touchscreen display and a software graphical user interface; and treatment hardware for treatment of the patient's right and left eyes using two Activators (Disposables). The Console provides the electrical power, user interface, treatment monitoring, treatment control and safeguard circuitry used for controlling the heat and pressure applied to the patient's eyelids by the Activators (Disposables).