PMA P010062S015
- Device
- Boston Orthokeratology (oprifocon A)
- Applicant
- Bausch & Lomb
- PMA number
- P010062
- Supplement
- S015
- Product code
- NUU
- Decision date
- 2025-12-16
- Classification
- Ophthalmic
- Generic name
- Lens, contact, orthokeratology, overnight
- Approval order statement
- installation and validation of two Large Diameter (Scleral) Lathes at the Bausch + Lomb facility located in Wilmington, MA
Current openFDA PMA Record#
- Device
- Boston Orthokeratology (oprifocon A)
- Applicant
- Bausch & Lomb
- PMA number
- P010062
- Supplement
- S015
- Product code
- NUU
- Generic name
- Lens, contact, orthokeratology, overnight
- Decision date
- 2025-12-16
- Decision code
- OK30
- Date received
- 2025-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- installation and validation of two Large Diameter (Scleral) Lathes at the Bausch + Lomb facility located in Wilmington, MA