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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameMEL 80 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system(193 nanometer wavelenght)
ApplicantCARL ZEISS MEDITEC, INC.
PMA NumberP060004
Date Received02/14/2006
Decision Date08/11/2006
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 06M-0342
Notice Date 08/25/2006
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the mel 80 excimer laser system. The device uses an optical zone of 6. 0 to 7. 0 mm in diameter and a transition zone of 1. 7 to 1. 9 mm for total ablation diameter of 7. 7 to 8. 9 mm, and is indicated for primary laser assisted in situ keratomileusis (lasik) treatments for: 1) the reduction or elimination of myopia of less than or equal to -7. 0 d, with or without refractive astigmatism of less than or equal to -3. 0 d, with a maximum mrse of -7. 00 d; 2) in patients who are 21 years of age or older; 3) with documentation of stable manifest refraction over the past year as demonstrated by change in sphere and cylinder of <=0. 5d.
Approval Order Approval Order
Supplements: S001 S002 
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