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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.
 
DevicePRECISION(TM) UV (VASURFILCON)
Classification Namelenses, soft contact, daily wear
Generic Namelenses, soft contact, daily wear
Regulation Number886.5925
Applicant
Alcon Laboratories, Inc.
6201 south freeway
fort worth, TX 76134-2099
PMA NumberP940013
Supplement NumberS005
Date Received04/04/1996
Decision Date10/07/1996
Product Code
LPL[ Registered Establishments with LPL ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the tinting of the device with an alternate, non-reactive, light blue-green locator tint (d&c green no. 6, c. I. No. 61565) using an in-monomer tinting process for the precision(tm) un (vasurfilcon a) hydrophilic contact lens for extended wear.
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