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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.
 
DeviceMEL 80 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
Carl Zeiss Meditec, Inc.
5160 hacienda drive
dublin, CA 94568
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
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 
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