Clearance Summary
BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENS received FDA 510(k) clearance under submission number K020927, sponsored by Bausch & Lomb. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2002-05-16.
- Submission: K020927
- Applicant / Sponsor: Bausch & Lomb
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2002-05-16
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.