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Upgrades to LADARVision
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Author:  Broken Eyes [ Mon Aug 21, 2006 1:39 pm ]
Post subject:  Upgrades to LADARVision

http://www.fda.gov/cdrh/pma/pmamay06.html

P970043/S019
5/1/06
Real-Time LADAR? 6000 Excimer Laser System Alcon Laboratories, Inc. Orlando, FL 32826 Approval for changes in the LADARVision? 4000 System including a new configuration of the illumination system, upgrades to the laser computer and operating system, and various other hardware and software changes intended to address compliance with EMI requirements, manage component obsolescence, reduce maintenance requirements, and enhance ergonomic and user interface features. The device, as modified, will be marketed under the trade name LADAR? 6000 Excimer Laser System.

P970043/S020
5/1/06
Panel LADARVision? 4000 Excimer Laser System and the LADAR? 6000 Excimer Laser System Alcon Laboratories, Inc. Orlando, FL 32826 Approval for the LADARVision? 4000 Excimer Laser System and the LADAR? 6000 Excimer Laser System. These devices use a 6.5 mm optical zone and a 9.0 treatment zone and are indicated for wave-front guided CustomCornea? laser assisted in-situ keratomileusis (LASIK): 1) for the reduction or elimination of hyperopia and hyperopic astigmatism of +0.75 D to less that +5.00 D of sphere with up to -3.00 D of cylinder (which has a magnitude less than or equal to the sphere in minus cylinder convention) and up to +5.00 cycloplegic spherical equivalent at the spectacle plane; 2) in patients 21 years of age or older; and 3) in patients with documented stability of refraction for the prior 12 months, as demonstrated by a change in sphere and cylinder of less than or equal to 0.50 D.

P970043/S022
5/2/06
Panel LADARVision? 4000 Excimer Laser System and the LADAR? 6000 Excimer Laser System Alcon Laboratories, Inc. Orlando, FL 32826 Approval for the LADARVision? 4000 Excimer Laser System and the LADAR? 6000 Excimer Laser System. These devices use a 6.5 mm optical zone and a 9.0 treatment zone and are indicated for wave-front guided CustomCornea? laser assisted in-situ keratomileusis (LASIK): 1) for the reduction or elimination of mixed astigmatism 1.00 D to less than 5.00 D cycloplegic cylinder magnitude at the spectacle plane, which is greater than the sphere magnitude, and the cylinder and sphere have opposite signs; 2) in patients 21 years of age or older; and 3) in patients with documented stability of refraction for the prior 12 months, as demonstrated by a change in sphere and cylinder of less than or equal to 0.50 D.

P970043/S023
5/1/06
180-Day LADAR? 6000 Excimer Laser System Alcon Laboratories, Inc. Orlando, FL 32826 Approval to increase the pulse repetition rate of the LADAR? 6000 Excimer Laser from 60 Hz to 92 Hx.

Author:  Broken Eyes [ Sun Dec 17, 2006 1:34 am ]
Post subject: 

P970043/S026

http://www.fda.gov/cdrh/pma/pmanov06.html

11/1/06

Real-Time LADARVision? 4000 and LADAR6000? Excimer Laser Systems and the CustomCornea? Surgery Planning Software Alcon Laboratories, Inc.

Orlando , FL

32826 Approval for a software change to the wavefront-image gathering sequence in the CustomCornea? Surgery Planning Software to allow for different pre-op and surgery days; a change to the LADAR6000? software to allow for conventional centration photos to be imported from the LADARWave? CustomCornea? Wavefront system; and, minor enhancements/bug fixes to the LADARVision? 4000 software, the LADAR6000? System software, and the CustomCornea? Surgery Planning Software.

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