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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameLASERSIGHT LASERSCAN LSX EXCIMER LASER SYSTEM FOR LASER-ASSITED IN SITU KERATOMILEUSIS (LASIK)
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system (193 nanometer wavelength)
ApplicantLASERSIGHT TECHNOLOGIES, INC.
PMA NumberP980008
Supplement NumberS005
Date Received12/19/2000
Decision Date09/28/2001
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 01M-0490
Notice Date 10/26/2001
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the lasersight laserscan lsx excimer laser system for laser-assisted in situ keratomileusis (lasik). The device is indicated for lasik: 1) for the reduction or elimination of myopia ranging from -0. 5 to less than -6. 0 diopters (d) spherical equivalent, with astigmatism less than or equal to 4. 5 d, as measured at the spectacle plane; 2) in patients with documentation of a stable manifest refraction defined as <= 0. 50 d, or <= 10% of preoperative spherical equivalent refraction (ser) shift over one year prior to surgery; and, 3) in patients who are 18 years of age or older.
Approval Order Approval Order
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