Clearance Summary
OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES received FDA 510(k) clearance under submission number K013445, sponsored by Florida Optical Engineering, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2001-12-26.
- Submission: K013445
- Applicant / Sponsor: Florida Optical Engineering, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2001-12-26
Classification & Regulation
This clearance is catalogued under FDA product code LPL and 21 CFR 886.5925, within the Ophthalmic review panel as a Class II device.