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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameVISX EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
Abbott Medical Optics, Inc.
510 coltonwood dr.
milpitas, CA 95035
HDE NumberH000002
Supplement NumberS001
Date Received03/07/2002
Decision Date05/10/2002
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 75 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for custom contoured ablations patterns (custom-cap) method of prk or lasik for treatment of decentered ablations from previous refractive surgery.
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