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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 NameTECHNOLAS 217A EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser
ApplicantBAUSCH & LOMB, INC.
PMA NumberP990027
Supplement NumberS002
Date Received11/24/2000
Decision Date05/17/2002
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 02M-0299
Notice Date 07/02/2002
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 the technolas 217a excimer laser system. This device is indicated for laser in-situ keratomileusis (lasik) treatments: 1) for the reduction or elimination of myopic astigmatism up to -12. 00 d mrse, with sphere between >-7. 00 d to -10. 99 d and cylinder between 0. 00 and <-3. 00 d; 2) in patients with documented evidence of a change in manifest refraction of less than or equal to 0. 50 diopters (in both cylinder and sphere components) for at least one year prior to the date of the pre-operative examination; and, 3) in patients who are 21 years of age or older.
Approval Order Approval Order
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