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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantBausch & Lomb
1400 N. Goodman St.
Rochester, NY 14603
PMA NumberP010062
Supplement NumberS007
Date Received10/13/2009
Decision Date02/19/2010
Product Code NUU 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
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