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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.
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system(193 nanometer wavelenght)
PMA NumberP060004
Supplement NumberS001
Date Received12/28/2007
Decision Date03/28/2011
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 11M-0256
Notice Date 04/25/2011
Advisory Committee Ophthalmic
Clinical Trials NCT00762281
Supplement Typepanel track
Supplement Reason change design/components/specifications - other
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. This device uses an optical zone of 6. 0 to 6. 5 mm in diameter and a transition zone of 2. 0 to 4. 0 mm for a total ablation diameter of 10. 0 mm, and is indicated for primary laser assisted in situ keratomileusis (lasik) treatments for: 1) the reduction or elimination of naturally-occurring hyperopia of less than or equal to +5. 0 d with or without refractive astigmatism of > +0. 5 and <= +3. 0d, with a maximum mrse of +5. 0d; 2) in patients who are 21 years of age or older; and 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