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The VISULAS 532s laser is intended for use in photocoagulating ocular tissues in the treatment of diseases of the eye. The laser energy is delivered via either transpupillary, delivery or intraocular endoprobe delivery.

The VISULAS 532s laser represents an improved version of the predicate Zeiss-Diode Pumped Solid State Laser (K925642). The improvement includes the following 2 modifications: In addition to the known laser slit lamp, the slit lamp adapter VISULINK 532/U or the Laser Indirect Ophthalmoscope LIO 532 may be used now as a laser application system. Laser console and user interface were improved to allow operation, setting, and monitoring of the different laser treatment procedures.

This device will be used in the same manner as all ophthalmic diagnostic devices used to obtain ocular measurements (for axial length, anterior chamber depth and corneal radius), and perform calculations to allow physicians to determine appropriate IOL power and type for implantation.

The IOLMaster is a non-invasive, non-contact system for measuring the parameters of the human eye required to determine the appropriate power of IOL for implantation, (axial eye length, anterior chamber depth, and corneal radius), and for calculating the optimal power of IOL. Axial eye length is measured using the principle of partial coherence interferometry (also referred to as laser Doppler interferometry), with a Michelson interferometer. Corneal radius is measured using traditional keratometery principles. whereby light from LEDs is projected on the cornea of the eve, and after image capturing of the reflected marks and image processing provides the measurement. Anterior chamber depth is measured by slit lamp illumination. The slit light is scattered by the cornea and the eye lens, generating an image of the cornea and the lens. The image is captured by a CCD-camera. Image processing and edge detection algorithms allow for calculation of the distance between the anterior surface of cornea and lens ( == anterior chamber depth). These three measurements provide the physician with the data required to calculate the power of IOL to use for a patient. The physician can then choose from one of up to five internationally accepted formulas, built into the IOLMaster, to perform the calculation. The IOL power is then calculated according to the IOL type. Users can also enter information regarding the different IOL types into the IOLMaster database, which can then be used to suggest the optimal IOL. This calculation and selection process is already performed by ultrasound and other diagnostic devices. However, the choice of formula and final determination of the appropriate IOL is at the physicians' discretion.

This device will be used in the same manner as all: (a) surgical microscopes are used and (b) as all lasers are used in ENT and general surgery not requiring photocoagulation. The device is primarily intended to allow surgeons to perform tissue ablation with minimal peripheral thermal effects. More specifically, the device can be used for: general surgery which does not require photocoagulation; and in ENT applications, including microsurgery in the middle ear, stapedoplasty, for preparation of sites for osteosynthesis, microsurgery on ossicles, tympanic membrane, ablative surgery on soft tissues (for example: ligament severance of the stapes muscle), and removal of exostosis.

The OPMI® TwinER Surgical Microscope is a surgical microscope with an integrated solid-state Er: YAG (Erbium Yttrium aluminum garnet) laser. The Er:YAG laser is used for the ablation of biological tissue. The OPMI® TwinER is designed for use in general surgery where coagulation is not required, and otology, rhinology, and laryngology ("ENT") applications. Because the Er: YAG laser operates in the 2,940 nm wavelength and is absorbed very well by water, it causes minimal damage to the peripheral tissues from thermal absorption. This makes the Er: YAG particularly effective in traditional and microsurgery in the ear. The therapy beam is a Class IV laser with adjustable power output between 10 mJ and 100 mJ. The OPMT® TwinER also uses an aiming beam to position the therapy beam, which operates in the 660-680 nm wavelength. The aiming beam is a Class IIIA laser with adjustable power output between 0.2 mW and 3 mW. The therapy and aiming beams are delivered to the surgical field via a micromanipulator. A mirror, which can be finely adjusted using a joystick, allows the exact positioning of the laser beam.

The Surgical Microscope Navigator (SMN) and the Surgical Tool Navigator (STN) System are a modular product group intended to provide the surgeon with navigational support during surgery They permit the surgical team to load radiological imaging studies onto a workstation equipped with image processing and visualization software. After correlation of the patient position with the images, (the registration procedure) the system displays the position, trajectory and other localization information of the current "tool" interactively throughout the surgical procedure.

The Surgical Microscope Navigator (SMN) and the Surgical Tool Navigator (STN) System are a modular product group intended to provide the surgeon with navigational support during surgery. The SMN's primary "tool" is a surgical microscope. The STN uses a variety of "Pointers" and instruments as tools. Both systems localize the tools in space via an industry standard infra-red LED based camera system. The LED's coordinates are then transferred to the workstation which in turn converts them to the coordinate system of the imaging data and interactively displays them.

The CPC Probe is used to reduce the intraocular pressure associated with the eye disease Glaucoma.

The Zeiss CPC Probe is a laser delivery system designed for use with the Visulas Diode II laser from Carl Zeiss. When used in tandem they form an ophthalmic laser treatment device. The contact probe is applied with slight pressure to the sclera and located approximately 1.5 mm behind the limbus. This method significantly increases the transmission of the sclera and also reduces the scattering of the laser beam. The power is adjusted and increased successively until the proper effect is heard. The power is then reduced and remaining coagulations can be performed if needed.

This device will be used in the same manner as all OCT scanner devices are used for two dimensional cross-sectional imaging of the posterior segment of the eye. It incorporates the original intended uses of our earlier claimed substantially equivalent products. It is used primarily for diagnosing and monitoring retinal diseases and disorders that manifest themselves in the posterior pole of the eye. Clinical studies with the OCT have demonstrated its effectiveness in detecting and quantifying the extent of macular edema, macular holes, retinal detachments and central serious chorioretinopathy.

In general OCT Scanners permit the user to obtain and analyze crosssectional tomograms of ocular tissue in a non-contact and non-invasive manner. The Humphrey Optical Coherence Tomography Scanner measures optical reflectivity to obtain cross sectional tomograms of the eye. The Humphrey OCT employs the principle of low coherence interferometry based upon the Michelson interferometer. In a Michelson interferometer, the light from a source is split into a sample path and a reference path containing a mirror. Light reflected back from the sample path and the reference path will create an interference pattern on a detector if the optical path lengths between the reference and sample are identical. Adjusting the length of the reference path will allow a semi-transparent sample, such as the retina, to be cross-sectionally scanned. The Super-Luminescent Diode (SLD) used in the Humphrey OCT Scanner permits a short coherence length in air. Accounting for the index of refraction of the eye, this translates to an even shorter coherence length within the retina. The SLD emits near infrared light which is scattered by the various interfaces and structures of the retinal tissue. As the reference arm is moved, a depth profile of the retina is produced which is similar to ultrasound A-scan. The profile plots variations in optical reflectivity between the different layers of the retina. Two mirrors mounted to galvanometers deflect the SLD beam within the eye. Scanning the retina in this manner produces cross-sectional images similar to ultrasound B-scan but of much higher resolution. The tomographic images of the retina produced by the OCT scanner provide an important tool in the diagnosis of retinal disorders and diseases that manifest themselves in the posterior pole of the eye.