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The Pulsair IntelliPuff Non-Contact Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma. The Pulsair Desktop Tonometer is indicated for measuring intraocular pressure without contacting the eye to aid in the screening and diagnosis of glaucoma.

The Keeler Pulsair Tonometer product family are non-contact tonometers and are used to measure intraocular pressure without contacting the eye to aid with the screening and diagnosis of glaucoma. The product family consists of the Pulsair Intellipuff (Hand Held device) and the Pulsair Desktop which is mounted on a desk. The Pulsair Intellipuff Tonometer has been designed using the same ergonomics as the predicate device described in 510(k) submission K990257 whilst the Pulsair Desktop Tonometer ergonomics have been adapted to suite the Desktop mounted market place. Both products use the same concept of measurement as the predicate device and contain many common components. All of the products consist of an air generation system in the form of a vacuum Diaphragm pump, an air reservoir, a solenoid valve, a light source and an opto-electronic platform which is used for position detection and IOP measurement. The basic concept of operation is the same. The user positions the instrument close to the patient's cornea using a targeting system. As the user moves the instrument closer to the patient, the reflection off the cornea from the built in light source increases until the predefined firing thresholds on the built in photodiodes have been met. Once this condition has been met, a quantised puff of air is automatically projected toward the patient's cornea. As the cornea flattens due to the force of the puff of air, the light being reflected off of the cornea changes shape which in turn changes the profile of the light being reflected back onto the photodiodes. The rate of change of this reflection is monitored by the photodiodes and converted into intraocular pressure in units of mmHg by the on board microprocessor.

Keeler PSL Classic Slit Lamp is an AC-powered Slit lamp biomicroscope. It is intended for use in eye examination of the anterior eye segment, from the cornea epithelium to the posterior capsule. It is used to aid in the diagnosis of diseases or trauma which affects the structural properties of the anterior eye segment.

The Keeler Portable Slit Lamp comprises a rechargeable hand held portable illuminated biomicroscope system and a desk mounted base charger unit that is powered from a low voltage (12V) power supply. The hand held unit incorporates a built-in rechargeable battery powering the illumination system. The illumination system and fixation targets are activated using a single/double click trigger located on the front of the grip/handle. To increase or reduce the light intensity there is a rheostat located below the eyepieces on the rear of the grip /handle. The 10 x and 16 x magnifications optical system is controlled using the lever located under the adjustable eyepieces.

The Keeler Cryomatic System and probes are for use in ophthalmic surgery in cryopexy procedures in refractory glaucoma, for retinal detachment, cryo destruction, cataract extraction, cryo destruction of lash follicles, extraction of fragments within the eye, and treatment of retinopathy of prematurity (ROP).

Cryomatic System and Probes comprising of: a) Cryomatic Console b) Cryomatic Probes

The Keeler Vamage Plus Indirect Ophthalmoscope is intended to examine the Cornea, aqueous, lens, vitreous and retina of the eye.

The Vantage Plus is a head mounted Binocular Indirect ophthalmoscope designed to be used by trained personnel for illuminating and viewing parts of the eye such as the Cornea and retina when used in conjunction with an ophthalmic lens. The instrument has two main elements i) The illumination element ii) the viewing element. The illumination element consists of a 6Volt, 5Watt Xenon filament lamp, a condensing lens, IR filtration, User filters for diagnostic purposes, variable stop sizes for increasing/decreasing light aperture sizes, a projection lens and an illumination mirror used by the user to direct the light. The binocular Viewing element consists of low powered Viewing Lenses (+2 dioptre) and directional mirrors which are adjustable to obtain optimal views of the eye. The unit has adjustable illumination levels and is powered by the same power sources to that used on the Vantage (Re: 510(k) K942104). To improve the ease of use of the instrument, the Vantage Plus combines the Aperture selector control and the Viewing mirror adjustments to achieve optimal instrument setting with minimum fuss. This feature is not present on the Vantage (Re: 510(k) K942104).

The Keeler Wide Angle Ophthalmoscope is intended to be used to examine the cornea, aqueous, lens, vitreous, and retina of the eye. It has the same operating principles and intended use as many competitive ophthalmoscopes already in commercial distribution. The device is intended to be used by trained personnel within a medical or school environment.

The Keeler Wide Angle Ophthalmoscope is a hand held indirect monocular device for use by trained personnel for viewing the cornea and retina of a patient. The viewing path in conjunction with the large solid angle projection of the illumination path provides two angles of view which provides larger fields of view than attainable with a conventional direct ophthalmoscope. The viewing optical system composes of two objective lenses, relay components and eyepiece provide an erect, un-reversed image of the patients retina to the doctor. The illumination path of the instrument consists of a filament lamp, a condensing system, two full mirrors and one semi-reflector mirror. The illumination path is imaged iust below the viewing optics axis as they combine at the semi-reflector mirror. The condensing lenses image the lamp filament essentially onto the patient's cornea. The filament image at the corneal plane is small permitting an increase ease of entry into undilated pupil. Any reflections of the filament from the surface of the cornea are trapped on light stops, which are positioned within the viewing optics. This allows the practitioner to obtain reflex free images of the retina.

The Keeler CryoMaster & Probes are for use in ophthalmic surgery in cryopexy for retinal detachment, cyclo destructive procedures in refractory glaucoma, extraction of fragments within the vitreous cavity, cataract extraction, cryo destruction of lash follicles for trichiasis, and treatment of retinopathy of prematurity (ROP).

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Measurement of the Intraocular Pressure

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Specular Observation of the tear film

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