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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 Namelens, contact, orthokeratology, overnight
Generic Nameoprifocon a rigid gas permeable contact lenses
Regulation Number886.5916
ApplicantBAUSCH & LOMB
PMA NumberP010062
Supplement NumberS007
Date Received10/13/2009
Decision Date02/19/2010
Product Code
NUU[ Registered Establishments with NUU ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of labeling changes for the boston orthokeratology (oprifocon a) shaping lens as a result of the post-approval study. The device is indicated for use in the reduction of myopic refractive error in non-diseased eyes. The lenses are indicated for overnight wear as part of bausch & lomb vision shaping treatment vst process for the temporary reduction of myopia up to 5. 00 diopters with eyes having astigmatism up to 1. 50 diopters.