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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 NameMEDITEC MEL 80 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic medical laser system(193 nanometer wavelenght)
ApplicantCARL ZEISS, INC.
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
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