PMA P010062S006

Device: BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S006
Product code: NUU
Decision date: 2008-02-21
Classification: Lens, Contact, Orthokeratology, Overnight
Generic name: Lens, contact, orthokeratology, overnight
Approval order statement: APPROVAL FOR WET SHIPPING, WITH STORAGE UP TO 30 DAYS, OF THE BOSTON EQUALENS, EQUALENS II AND BOSTON ORTHOKERATOLOGY SHAPING RIGID GAS PERMEABLE CONTACT LENSES IN BOSTON SIMPLUS MULTI-ACTION SOLUTION.

Current openFDA PMA Record#

Device: BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT
Applicant: Bausch & Lomb
PMA number: P010062
Supplement: S006
Product code: NUU
Generic name: Lens, contact, orthokeratology, overnight
Decision date: 2008-02-21
Decision code: APPR
Date received: 2008-01-31
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR WET SHIPPING, WITH STORAGE UP TO 30 DAYS, OF THE BOSTON EQUALENS, EQUALENS II AND BOSTON ORTHOKERATOLOGY SHAPING RIGID GAS PERMEABLE CONTACT LENSES IN BOSTON SIMPLUS MULTI-ACTION SOLUTION.