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LipiScan™ Dynamic Meibomian Imager is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of the meibomian glands.

The LipiScan™ Dynamic Meibomian Imager (DMI) (Model DMI-1000) is a bench-top ophthalmic camera used to image the meibomian glands. LipiScan™ contains a computer system, electronics, chin and forehead rest, camera and attached lens, illuminator, touchscreen display, handheld near-infrared (IR) lid everter and power supply. The chin and forehead rest and handheld near IR lid everter are the only components of the device that contact the patient's intact skin. LipiScan™ uses near infrared (NIR) illumination and an NIR-sensitive high-resolution camera to image the meibomian glands. The tissue between the meibomian glands and the surface of the eyelid is transparent to NIR light; the glands reflect NIR wavelengths, allowing them to be imaged. The images of the glands may be viewed on the computer screen display and in a printed report.

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 LipiView® II Ocular Surface Interferometer is an ophthalmic imaging device intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of: • Specular (interferometric) observations of the tear film. Using these images, LipiView® II measures the absolute thickness of the tear film lipid layer. • Meibomian glands under near-infrared (NIR) illumination • The ocular surface and eyelids under white illumination All of these image types can be photographically documented and visually monitored.

The LipiView® II Ocular Surface Interferometer is a bench-top device used as an ophthalmic camera for imaging the lipid layer of the tear film, meibomian glands, ocular surface and eyelids. There are three imaging modes: Lipid, Gland and Ocular. LipiView II contains a computer system and electronics, two position chin and forehead rest, camera and lens, motion stage, illuminator and touch screen display. LipiView II includes pushbutton controls and handheld near-infrared lid everter for gland imaging.

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 LipiView® Ocular Surface Interferometer is intended to image the tear film. The LipiView® Interferometer is a prescription device for use by a physician during an in-office exam. Indications for Use: The LipiView® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented. Using these images, the LipiView Interferometer measures the absolute thickness of the tear film lipid layer.

The LipiView Ocular Surface Interferometer is a bench-top imaging device containing a computer system and electronics, chin rest and forehead rest, camera and zoom lens, illuminator and a touch screen display. The LipiView® Interferometer operates on the principle of white light interferometry and provides an interferometry color assessment of the tear film by specular reflection. The computer system captures a video image file that is recorded over time since the interference pattern changes as the tear film is distributed across the cornea during blinking. The video image of the ocular surface may be viewed on the computer screen display, in a printed report, or captured on video and exported to USBattached storage or a mapped network drive. The LipiView® Interferometer has been modified to software version 2.0, which includes changes to refine the interferometric color matching and blink detection methods used on interferometric images and to provide minor usability enhancements.

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).

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.

The physician uses the LipiFlow® System in an in-office procedure to control the application of warmth and massage to the eyelids. Two components comprise the LipiFlow® System, the Disposable unit and the Handheld Control System (HCS). The Disposable unit is a sterile, single-use, biocompatible unit that is inserted around the patient's eyelids. The Disposable unit consists of a combined Eye Cup and Lid Warmer with attached tubing and wiring that connect to the Control unit with a connector. The Eye Cup contacts the outer eyelid and contains a soft, flexible bladder that intermittently inflates with air to provide controlled massage pressure to the eyelids. The Lid Warmer contacts the inner eyelid surface and provides controlled, outward directional (away from the eye and towards the eyelid) heat to the inner eyelid. The Lid Warmer has a smooth surface and edges, where the circumference rests lightly on the conjunctiva of the eye. The Lid Warmer shape vaults above the eye surface to prevent corneal contact. The Lid Warmer has an integrated insulator (also referred to as the Insulating Scleral Lens) to shield the eye from thermal transfer and redundant temperature sensors to ensure precise control of the temperature. The HCS is a battery-operated, hardware interface that allows the physician to control the application of heat and pressure, which is delivered via a single, 12-minute treatment. The HCS regulates the level of heat and pressure that can be applied during treatment. The HCS consists of a visual Light Emitting Diode (LED) display, power switch, push button, electronic circuit board, pump, pressure regulator, pressure sensor, dump valve, connector and battery compartment. The HCS displays information to the physician including: the temperature at the Disposable; line air-pressure to the Disposable; treatment time; low pressure selection indicator; and system messages, such as low battery, a system error, or inadequate connection to the Disposable. By visualizing the temperature and pressure LED displays, the physician can determine when the therapeutic temperature is reached and the relative pressure being applied. The push button starts the application of heat and pressure and can be depressed again at any time to pause the treatment, which immediately stops the therapeutic application. In the event that the physician desires to reduce pressure for patient comfort, the pressure can be reduced by 30% (Low Pressure Mode) by pressing and holding the push button. The HCS uses three AA (1.5V) Lithium disposable batteries.

The LipiView® Ocular Surface Interferometer is an ophthalmic imaging device that is intended for use by a physician in adult patients to capture, archive, manipulate and store digital images of specular (interferometric) observations of the tear film, which can be visually monitored and photographically documented.

The LipiView® Ocular Surface Interferometer is a bench-top imaging device containing a computer system and electronics, chin rest and forehead rest, camera and zoom lens, illuminator and a touch screen display. The LipiView® Interferometer operates on the principle of white light interferometry and provides an interferometry color assessment of the tear film by specular reflection. The computer system captures a video image file that is recorded over time since the interference pattern changes as the tear film is distributed across the cornea during blinking. The video image of the ocular surface may be viewed on the computer screen display and in a printed report.