Biomedics 55 Asphere; Biomedics Toric
FDA premarket approval P890023/S055 · decided 2025-07-31
Approval details
- PMA number
- P890023
- Supplement
- S055
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biomedics 55 Asphere; Biomedics Toric
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- The Cooper Companies
- Date received
- 2025-07-17
- Decision date
- 2025-07-31
- Days to decision
- 14 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- Statement
- reintroduction of Biomedics 55 Asphere and addition of Biomedics Toric on the LVA1 manufacturing line at the CooperVision facility in Scottsville, NY
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.