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The LenSx Laser System is indicated for use: - In the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery. - In the creation of a lamellar cut/resection for lamellar keratoplasty, and in the creation of a penetrating cut/incision for penetrating keratoplasty. - In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

The LenSx Laser System uses focused femtosecond laser pulses to create incisions and separate tissue in the lens capsule, crystalline lens, and the cornea. Individual photodisruption locations are controlled by repeatedly repositioning the laser focus. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incision or tissue separation. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a Patient Interface accessory that is placed on the surface of the cornea and fixes the eye with respect to the delivery system. This 510(k) premarket notification is being submitted to seek clearance for an additional patient interface accessory to be offered for use with cataract procedures in addition to the original patient interface accessory to the LenSx Laser System (cleared under K120732 for cataract and lamellar resection procedures). The SoftFit Patient Interface differs from the original Patient Interface (K120732) in that it has an extended suction ring skirt that enables positioning of a soft contact lens against the internal surface of the patient interface glass. The soft contact lens is similar to a standard daily wear contact lens indicated for the correction of ammetropia, with a slightly modified edge to enable fitting into the SoftFit Patient Interface. The materials and manufacturing processes used for the soft contact lens component of the proposed SoftFit Patient Interface accessory are identical to the processes used for the predicate daily wear soft contact lens (K100244). With the soft contact lens insert in place, the SoftFit Patient Interface is then mounted onto the LenSx laser system for docking onto the eye in a manner that is identical to the original LenSx Laser Patient Interface. As a result, use of the soft contact lens substantially reduces intraocular pressure (IOP) during the laser procedure, enhancing comfort and addressing potential concerns in patients with a history of glaucoma. For cataract procedures, either a LenSx Laser Patient Interface or a SoftFit Patient Interface may be used. The original LenSx Laser Patient Interface is used for keratoplasty and corneal flaps.

The LenSx Laser System is indicated for use: - · In the creation of corneal cuts/incisions, anterior capsulotomy and laser phacofragmentation during cataract surgery. Each of these procedures may be performed either individually or consecutively during the same surgery. - · In the creation of a lamellar cut/resection for lamellar keratoplasty, and in the creation of a penetrating cut/incision for penetrating keratoplasty - · In the creation of a corneal flap in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea

The LenSx Laser System uses focused femtosecond laser pulses to create incisions and separates tissue in the lens capsule, crystalline lens, and the cornea. Individual photodisruption locations are controlled by repeatedly repositioning the laser focus. The light pulse is focused into a sufficiently small spot in order to achieve photodisruption of the tissue inside the focus. A tiny volume of tissue, a few microns in diameter, is thereby photodisrupted at the laser focus. The surgical effect is produced by scanning thousands of individual pulses per second to produce a continuous incisions or tissue separation. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired surgical target location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. The laser pulses are delivered through a sterile, disposable applanating lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system. The LenSx Laser System proposed in this 510(k) premarket notification is a modification of the previously cleared LenSx Laser System, manufactured by Alcon LenSx, Inc. (K101626). It is essentially the same laser system with the addition of a new indication for use, namely the creation of a corneal flap in patients undergoing LASIK surgery or other treatments requiring initial lamellar resection of the cornea.