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BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT

FDA premarket approval P010062/S001 · decided 2004-08-02

Approval details

PMA number
P010062
Supplement
S001
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Trade name
BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENSES FOR OVERNIGHT WEAR FOR B&L VISION SHAPING TREATMENT
Generic name
Lens, contact, orthokeratology, overnight
Applicant
Bausch & Lomb
Date received
2004-07-06
Decision date
2004-08-02
Days to decision
27 days
Decision code
APPR
Product code
NUU
Advisory committee
Ophthalmic
Expedited review
No
Location
Rochester, NY
Statement
APPROVAL FOR THE PROTOCOL TO BE USED TO ADD CONTACT LENS FINISHING LABORATORIES TO MANUFACTURE THE SUBJECT DEVICE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT AND IS INDICATED FOR USE IN THE REDUCTION OF MYOPIC REFRACTIVE ERROR IN NON-DISEASED EYES. THE LENSES ARE INDICATED FOR OVERNIGHT WEAR FOR THE TEMPORARY REDUCTION OF MYOPIA UP TO 5.00 DIOPTERS WITH EYES HAVING

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