Clearance Summary
SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS received FDA 510(k) clearance under submission number K061157, sponsored by Bausch & Lomb. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2006-06-22.
- Submission: K061157
- Applicant / Sponsor: Bausch & Lomb
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2006-06-22
Classification & Regulation
This clearance is catalogued under FDA product code MVN and 21 CFR 886.5925, within the Ophthalmic review panel as a Class II device.