PMA P890023S055

Device: Biomedics 55 Asphere; Biomedics Toric
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S055
Product code: LPM
Decision date: 2025-07-31
Classification: Ophthalmic
Generic name: Lenses, soft contact, extended wear
Approval order statement: reintroduction of Biomedics 55 Asphere and addition of Biomedics Toric on the LVA1 manufacturing line at the CooperVision facility in Scottsville, NY

Current openFDA PMA Record#

Device: Biomedics 55 Asphere; Biomedics Toric
Applicant: The Cooper Companies
PMA number: P890023
Supplement: S055
Product code: LPM
Generic name: Lenses, soft contact, extended wear
Decision date: 2025-07-31
Decision code: OK30
Date received: 2025-07-17
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: reintroduction of Biomedics 55 Asphere and addition of Biomedics Toric on the LVA1 manufacturing line at the CooperVision facility in Scottsville, NY