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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 NameSVS APEX PLUS EXCIMER LASER WORKSTATION
Classification Nameexcimer laser system
Generic Nameexcimer laser system
ApplicantSUMMIT TECHNOLOGY, INC.
PMA NumberP930034
Supplement NumberS013
Date Received02/11/1999
Decision Date10/21/1999
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1591
Notice Date 11/03/2000
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the svs apex plus excimer laser workstation and emphasis(r) "m" discs (m00-m09) these devices are indicated to perform lasik: 1) for the reduction or elimination of myopia ranging from 0. 0 to -14. 0 diopters (d) with or without astigmatism ranging from -0. 5d to -5. 0d; 2) in patients 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction (+0. 5d) over the past year.
Approval Order Approval Order
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