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The LenSx Laser is indicated for use in patients undergoing cataract surgery for removal of the crystalline lens. Intended uses in cataract surgery include anterior capsulotomy, phacofragmentation, and the creation of single plane and multi-plane arc cuts/incisions in the cornea, each of,which may be performed either individually or consecutively during the same procedure. The LenSx Laser is indicated for use in patients undergoing penetrating keratoplasty for full thickness corneal replacement and in patients undergoing lamellar keratoplasty for partial thickness corneal replacement. The intended use in penetrating and lamellar keratoplasty includes the creation of single plane and multi-plane arc and circular cuts/incisions in the cornea.

The LenSx Laser System uses focused femtosecond laser pulses to create incisions and separates tissue in the lens capsule, crystalline lens and 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 is an ophthalmic surgical laser that has previously been cleared for use in: - • Anterior capsulotomy (K082947), performed by delivering a cylindrical pattern of laser pulses to intersect the anterior lens capsule. - · Phacofragmentation (K090452), performed by delivering series of laser pulses to form two intersecting ellipsoidal planes that divides the lens into quadrants. - . Cuts/incisions for keratoplasty (K092647) which are performed by delivering a pattern of circles and arcs with programmable incision length and depth.

The LenSx 550 Laser System is indicated for anterior capsulotomy and laser phacofragmentation during cataract surgery. The anterior capsulotomy and phacofragmentation procedures may be performed either individually or consecutively during the same surgery.

The LenSx 550 Laser is an ophthalmic surgical laser that has previously been cleared for use in anterior capsulotomy during cataract surgery (K082947). The LenSx 550 generates femtosecond laser pulses that are scanned in a three-dimensional pattern in the eye. Localization of these laser pulses is accomplished by an aiming beam that identifies the surfaces of the lens, and an off-the-shelf, disposable contact lens and suction ring assembly that fixates the eye relative to the delivery system. As described in K082947, anterior capsulotomy is performed by delivering a cylindrical pattern of laser pulses to intersect the anterior lens capsule. The same surgical device, with only minor software changes, is now also being proposed for use in phacofragmentation during cataract surgery. As described in this premarket notification, laser phacofragmentation divides the lens into quadrants, in the same way that division of the lens into quadrants is performed with standard ultrasound phacofragmentation in the initial step of phacoemulsification. To perform phacofragmentation, the LenSx system delivers a series of laser pulses to form two intersecting ellipsoidal planes. Photodisruption of the lens tissue in this pattern, which appears as a cross from a surgical (top) view, segments the nucleus into four sections before the eye is physically entered by any instruments or devices. Following entry into the eye and then into lens, the fragmented nuclear quadrants created by the LenSx 550 are further fragmented and removed using a standard phacoemulsification probe.

The LenSx 550 Laser System is indicated for use in the creation of a partial thickness cut/incision for lamellar keratoplasty and in the creation of a full-thickness cut/incision for penetrating keratoplasty.

The LenSx 550 Laser is an ophthalmic surgical laser indicated for use in the creation of a penetrating cut/incision for penetrating and lamellar keratoplasty. Consistent with commercially available femtosecond lasers (Product Code GEX, 878.4810 and OOE, 886.4390) the LenSx 550 Laser creates incisions using focused femtosecond laser pulses. Individual photodisruption locations are controlled by repositioning the laser focus in the cornea. 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. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired 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 an off-the-shelf, disposable contact lens and suction ring assembly that contacts the cornea and fixes the eye with respect to the delivery system.

The LenSx 550 Laser System is indicated for anterior capsulotomy during cataract surgery.

The LenSx 550 Laser is an ophthalmic surgical laser intended for use in patients requiring an anterior capsulotomy. The LenSx 550 Laser focuses a beam of low energy pulses of infrared light into the anterior lens. Consistent with commercially available femtosecond lasers used for lamellar resection of the cornea (GEX, 878.4810), the cutting effect is produced by scanning individual pulses to produce a continuous incision. The location of the tissue photodisruption is controlled by moving the focus of the laser beam to the desired location. A computer-controlled scanning system directs the laser beam throughout a three-dimensional pattern to produce an incision. Finally, the laser pulses are delivered through an off-the-shelf disposable contact lens that contacts the cornea and fixes the eye with respect to the delivery system.