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Device | ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS |
Generic Name | Lens, contact, orthokeratology, overnight |
Regulation Number | 886.5916 |
Applicant | BAUSCH & LOMB 1400 NORTH GOODMAN ST. ROCHESTER, NY 14603-0450 |
PMA Number | P010062 |
Supplement Number | S007 |
Date Received | 10/13/2009 |
Decision Date | 02/19/2010 |
Product Code |
NUU |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
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. |