ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
FDA premarket approval P010062/S007 · decided 2010-02-19
Approval details
- PMA number
- P010062
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS
- Generic name
- Lens, contact, orthokeratology, overnight
- Applicant
- Bausch & Lomb
- Date received
- 2009-10-13
- Decision date
- 2010-02-19
- Days to decision
- 129 days
- Decision code
- APPR
- Product code
- NUU
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Rochester, NY
- 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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