- Device
- Boston Orthokeratology (oprifocon A) Shaping lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment
- Applicant
- Bausch & Lomb
- PMA number
- P010062
- Supplement
- S014
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2025-02-20
- Decision code
- APPR
- Date received
- 2024-11-22
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- implementing a design module of the existing software for generating lathe cutting files to provide alternative posterior lens designs for Boston Orthokeratology (oprifocon A) Shaping Lens for Overnight Wear for Bausch + Lomb Vision Shaping Treatment