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The Pocket III is intended to be used in ophthalmology clinical applications for measurement of corneal thickness by ultrasonic means with pachymetry. This device should be operated by doctors or other appropriately-trained healthcare professionals and should be used in health institutions. The device is not intended for fetal use.

The Pocket III is a small hand-held device in pen-shaped design. Measurement results appear numerically on the LCD graphic display. The user can perform a basic cable transfer (USB-C) or activate Bluetooth to export data to a computer. The Pocket III is equipped with an integrated 30 MHz pachymetry probe. The ultrasonic transducer makes contact with, and transmits ultrasonic pulses through, the surface cornea. Echoes are returned from the anterior and posterior surfaces of the cornea.

CAPSULO is indicated for photodisruption of ocular tissue using light energy emitted by a Nd: YAG laser, including discission of the posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy.

The Yttrium Aluminum Garnet (YAG) ophthalmic laser system produces short pulses of focused infrared light at a wavelength of 1.064 nm. These pulses can be precisely positioned using a slit lamp microscope and a dual-point aiming system. The energy contained in a short pulse is concentrated by focusing a very small spot (10 um) so that the formation of plasma is at the focal point. The firing causes an acoustic wave that radiates from the focal point and breaks the near tissue which is known as disruptive photo-effect. Once formed, plasma absorbs and further diffuses incident light, protecting deeper structures. Furthermore, the divergence of the beam after the focal point protects the retina from damage that could otherwise occur by the absorption of concentrated energy in the Nd: YAG treatment beam. As the treatment energy is increased, the size of the plasma formed also increases, until a larger and stronger acoustic wave is produced. For increased energy, it is necessary to focus the treatment beam further behind the ocular structure being treated. The Nd: YAG 1064 nm laser operates at a nano-second pulse rate and the laser energy is delivered to the treatment site using the integrated slit lamp.

The AXIALIS Ophthalmic Ultrasound System and the probes that are indicated for diagnostic imaging and biometric measurement of the eye including: - · Axial Length measurement of the eye by ultrasonic means. - · Implanted IOL power calculation, using the Axial Length measurement. - · Measurement of corneal thickness by ultrasonic means.

The AXIALIS Ophthalmic Ultrasound System is an ultrasonic system for ophthalmology which consists of a base and probes. The base performs the same calculations and displays as the predicate device, the Quantel Medical COMPACT TOUCH. The A-scan probe for biometry and pachymetry is identical to the predicate device.

The Vitra 810 is intended for retinal photocoagulation, laser trabeculoplasty, transscleral cyclophotocoagulation, transscleral retinal photocoagulation, iridotomy, including the following: Retinal photocoagulation for the treatment of: Diabetic retinopathy including: Nonproliferative retinopathy Macular edema Proliferative retinopathy Retinal Tears, Detachments and Holes Lattice degeneration Age-related macular degeneration (AMD) with choroidal neovascularization (CNV) Retinopathy of prematurity Sub-retinal (choroidal) neovascularization Central and Branch Retinal Vein Occlusion Laser Trabeculoplasty, Iridotomy, Transscleral Cyclophotocoagulation for the treatment of glaucoma, including: Primary open angle Closed angle Refractory Glaucoma (recalcitrant/uncontrolled)

The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the retinal diseases and glaucoma. The Vitra 810 is a laser system which emits a treatment beam at 810 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye. The laser is used to treat the anterior and posterior segments of the eye. The laser is particularly well suited for treating the eye because it has minimal effect on transparent tissues and materials. This means that the laser can be efficiently delivered to opaque structures of the eye through the transparent cornea, aqueous humor, lens, and vitreous humor. This allows many conditions to be treated by non-invasive techniques. Laser energy is delivered to opaque structures within the eye by means of laser delivery systems including slit lamp, indirect ophthalmoscope, operating microscope, cyclophotocoagulation probe and laser probe. The standard delivery system includes a lens system to focus the laser energy and vary the size of the laser spot in the plane of observation of the slit lamp, for example. The laser energy is delivered to the delivery system by the means of a flexible fiber optic. For most procedures, a laser contact lens is used to direct the laser energy to the part of the eye being treated. The contact lens may have mirrors so that laser energy can be delivered to areas of the retina behind the iris, or into the angle so that the trabecular meshwork can be treated. The contact lens also helps to hold the eye open and still so that the laser energy can be delivered effectively.

The Vitra 2 is for use in the treatment of ocular pathology of anterior segments including retinal photocoagulation and pan retinal photocoagulation of vascular and structural abnormalities of the retina and choroids including: - · Proliferative and nonproliferative diabetic retinopathy - Choroidal neovascularization - · Branch retinal vein occlusion - · Treatment of choroidal neovascularization associated with wet Age-related macular degeneration - · Retinal tears and detachments - · Macular edema

The Vitra 2 is a laser system which emits a treatment beam at 532 nm and is intended for use in photocoagulation of ocular tissues in the treatment of diseases of the eye.Laser energy is delivered to opaque structures within the eye by means of delivery systems including slit lamp, indirect ophthalmoscope, operating microscope and endocular probe. The standard delivery system includes a lens system to focus the laser energy and vary the size of the laser spot in the plane of observation of the slit lamp, for example. It also includes a Multispot delivery system made by scanner motors which can deliver several spots to the retina in a pattern. The laser energy is delivery system by the means of a flexible fiber optic. For most procedures, a laser contact lens is used to direct the laser energy to the part of the eye being treated. The contact lens also helps to hold the eye open and still so that the laser energy can be delivered effectively. The Quantel Medical VITRA 2 includes a Scanning Laser Delivery System adaptor with scanner controls that may be coupled to a slit lamp. Once activated by the user, the VITRA 2 delivers a predetermined pattern by sequentially scanning the placement of the laser spots and the emission of the individual pulses of laser light. Treatment is initiated by pressing the footswitch and may be aborted by releasing the footswitch.

The Quantel Medical ABSOLU is intended to be used for: -Axial Length measurement of the eye by ultrasonic means; -Implanted IOL power calculation, using the Axial Length measurement; - Visualization of the interior of the eye and the orbit by A and B scans.

The ABSOLU is a high definition multifunction ophthalmic ultrasound system used for the following intended use: - -Axial Length measurement of the eye by ultrasonic means; - Implanted IOL power calculation, using the axial length measurements; - - Visualization of the interior of the eve and the orbit by A and B scans. -

The COMPACT TOUCH Ophthalmic Ultrasound System and the probes that are used with it are indicated for diagnostic imaging and biometric measurement of the eye including: - Visualization of the interior of the eye and the orbit by A and B scans. - Axial Length measurement of the eye by ultrasonic means. - Implanted IOL power calculation, using the Axial Length measurement. - Measurement of corneal thickness by ultrasonic means.

The COMPACT TOUCH Ophthalmic Ultrasound System is an ultrasonic system for ophthalmology. It is a modification to the COMPACT TOUCH® cleared in K094038. Similar to the previous version of the device, it consists of a base and probes. The Base performs the same calculations and displays as the predicate COMPACT TOUCH®. The A-scan probe for biometry and pachymeter is identical to the predicate while the B-scan probe has an increased transducer frequency of 15 Hz which allows for improved measurement accuracy of ± 0.115 mm.

The Easyret® is indicated for use in the treatment of ocular pathology of anterior and posterior segments including, retinal photocoagulation, pan retinal photocoagulation for vascular and structural abnormalities of the retina and uvea including: - Proliferative and severe nonproliferative diabetic retinopathy, - Choroidal neovascularization - Branch retinal vein occlusion - Treatment of choroidal neovascularization associated with wet age-related macular degeneration - Retinal tears and detachments, - Certain forms of macular edema - Retinopathy of Prematurity - Iridotomy in angle closure glaucoma, and trabeculoplasty in open angle glaucoma

Easyret® is an integrated photocoagulation laser system including a slit lamp and a single column table. It provides a yellow laser beam (577nm). Easyret® laser is available with the following configurations: - A single slit lamp delivery system: With this model two different slit lamps manufactured by CSO (CSO SL 9800 5x and CSO SL 9900 5x) are available. These slit lamps models have been cleared under K992836. - A slit lamp delivery system and a laser indirect ophthalmoscope (LIO) optional port In addition to the slit lamp delivery system, an optional LIO (laser indirect ophthalmoscope) can be used with the laser. Quantel Medical recommends the use of the following LIO models: Heine Omega 500 and Keeler Vantage +. The touch screen includes a user interface where laser treatment settings such as power, pulse duration, spot size treatment and aiming beam intensity level can be programmed. The user interface allows the physician to quickly select and access the following 3 treatment modes: - Monospot treatment: This selection allows the user to carry out thermal "traditional" laser treatment using single spot via 4 delivery modes: Single, Repeat, Painting or Continuous. - -MultiSpot treatment: The MultiSpot mode allows automatically consecutive several laser spots according a pattern selected and the treatment patterns are customizable: square, circle, triple arc and macular grid. - SubLiminal treatment: The sequencing (SubLiminal mode, or sub-threshold) is used to split the energy delivery into several successive very short pulses (microseconds) separated by a cooling time (interval). Feedback to the user, such as laser operating state, number of performed laser spots, etc. is provided through the user interface. The laser treatment can be initiated by pressing on a footswitch and aborted by releasing it.

OPTIMIS FUSION YAG: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy. OPTIMIS FUSION SLT: Selective Laser Trabeculoplasty OPTIMIS FUSION YAG/SLT: photodisruption of ocular tissue using light energy emitted by a Nd: YAG Laser, including discission of posterior capsule of the eye (posterior capsulotomy), and discission of pupillary membranes (pupillary membranectomy) in aphakic and pseudophakic patients, and iridotomy; and Selective Laser Trabeculoplasty

The QUANTEL MEDICAL OPTIMIS FUSION is an ophthalmic surgical laser designed for performing photodisruption of ocular tissue using laser energy emitted by a Nd:YAG laser including discission of the posterior capsule of the eye (posterior capsulotomy), discission of the pupillary membranes (pupillary membranectomy), and iridotomy/iridectomy; and selective laser Trabeculoplasty. The Family of OPTIMIS FUSION Ophthalmic Lasers. Delivery Device and Accessories consists of the following models: 1) OPTIMIS FUSION YAG a Nd: YAG Laser providing-switched laser pulses at a wavelength of 1064 nm for use in photodisruption of ocular tissue (posterior capsulotomy, pupillary membranectomy, iridotomy/iridectomy). The 1064 treatment beam delivers 4 ns, 0.3 -10mJ adjustable and selectable single, double or triple pulse of energy. It is conditioned trough beam shaping optics to generate a photodisruption micro pulse of plasma at a precision adjustable location relative to the visual focal plane (located at slit lamp center of rotation) and along the slit lamp objective lens axis. A twin aiming beam is also focused by the slit lamp objective to a converging 10 um spot located at the focal point of the lens. The focal point of photodisruption is adjustable 150um in the posterior direction and -150um in the anterior direction by the physician relative to this convergence of the twin aiming beams. 2) OPTIMIS FUSION SLT a Nd: YAG Laser providing Q-switched frequency doubled pulses at a wavelength of 532 nm for use in Selective Laser Trabeculoplasty. The treatment beams delivers a 4 nsec. 0.3-2mJ adjustable single pulse of energy. The aiming and treatment beams are coaxial with each other and focussed by the slit lamp objective to a 400um spot at the focal point of the lens. 3) OPTIMIS FUSION YAG/SLT a Nd: YAG Laser providing Q-switched laser pulses at a wavelength of 1064 nanometers for use in photodisruption or O-switched frequency doubled pulses at a wavelength of 532 nm for use in Selective Laser Trabeculoplasty. depending upon the mode selected. The OPTIMIS FUSION YAG/SLT contains two aiming beam modules that produce a single beam for the 532nm mode and a dual beam for the 1064nm mode, respectively. For each OPTIMIS FUSION model, the physician controls delivery of laser energy from the OPTIMIS FUSION control display unit and activates the treatment laser beam with a footswitch or joystick pushbutton. In addition, a laser slit lamp adaptor may be coupled to each of the above OPTIMIS FUSION models and connected to a currently cleared QUANTEL MEDICAL 532nm photocoagulator (VITRA (K04236), SUPRA (K07776), VITRA MULTISPOT (K122251)) to allow to the physician to use the Slit Lamp Adaptor to deliver 532 nm continuous wave laser energy for retinal photocoagulation. The OPTIMIS FUSION produces short, individual pulses of focused laser light with wavelengths of either 1064 nm or 532 nm. depending on the selected operational mode. Using a slit lamp microscope and aiming beam, the pulsed light is accurately targeted on a structure within the patient's eye. When the photodisruptor mode is selected, the treatment wavelength is 1064nm. A twinaiming beam targets the area of tissue disruption. The energy contained within a single short pulse is concentrated by focusing to a very small spot size so that plasma formation occurs at the focal point. This creates an acoustic wave which disrupts nearby tissue. When the SLT mode is selected, the treatment wavelength is 532nm. A coaxial aiming beam targets the trabecular meshwork via a contact lens. The SLT treatment laser provides a low energy, short pulse of laser light that produces a thermal effect in pigmented cells in the trabecular meshwork.

Selective Laser Trabeculoplasty (SLT)

SOLUTIS is a Q-switched, frequency doubled Nd:YAG laser providing a wavelength of 532 nm for use in Sclective Laser Trabeculoplasty. The treatment beam delivers a 4ns, 0.2-2 mJ adjustable single pulse of energy. The aiming beam and treatment beams are coaxial with each other and focused by the slit lamp objective to a 400um spot at the focal point of the lens. The SOLUTIS is compatible with Haag Streit 900 BM and Haag Streit 900 BQ slit lamps only.