Clearance Summary
PROCLEAR ULTRAVUE MULTIFOCAL AND PROCLEAR ULTRAVUE 2000T MULTIFOCAL TORIC (OMAFLICON A) SOFT (HYDROPHILIC CONTACT LENS) received FDA 510(k) clearance under submission number K043129, sponsored by Opti-Centre Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2005-01-12.
- Submission: K043129
- Applicant / Sponsor: Opti-Centre Laboratories
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2005-01-12
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.