Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
FDA premarket approval P080011/S192 · decided 2025-09-22
Approval details
- PMA number
- P080011
- Supplement
- S192
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Toric Multifocal and Biofinity XR Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2025-08-27
- Decision date
- 2025-09-22
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- introduction of a collation and packaging machine at the CooperVision, Inc. facility located 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.