Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio
FDA premarket approval P080011/S199 · decided 2026-03-18
Approval details
- PMA number
- P080011
- Supplement
- S199
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio
- Generic name
- Lenses, soft contact, extended wear
- Applicant
- CooperVision, Inc.
- Date received
- 2026-02-26
- Decision date
- 2026-03-18
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LPM
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- San Ramon, CA
- Statement
- introduction of two new osmometers at the CooperVision, Manufacturing, Ltd. facility located in Hamble, United Kingdom
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