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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 SURGICAL, INC.
PMA NumberP990027
Supplement NumberS004
Date Received12/14/2001
Decision Date02/25/2003
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 03M-0174
Notice Date 04/28/2003
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 technolas 217a excimer laser system. The device uses an optical zone treatment range from 5. 00 mm to 6. 00 mm with a blend zone of 1. 90 mm for spherical hyperopia and 1. 75 mm for hyperopic astigmatism. The laser is locked out for refractive corrections greater than +4. 00 d sphere and greater than +2. 00 d cylinder. The device is indicated for laser in-situ keratomileusis (lasik) treatments: 1) for the reduction or elimination of low-to-moderate naturally occurring hyperopia up to +4. 00 diopters (d) mrse, with sphere between +1. 00 to +4,00 d with or without refractive astigmatism up to +2. 00 d at the spectacle plane; 2) in patients who are 21 years of age or older; and, 3) 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.
Approval Order Approval Order
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