Clearance Summary
SOFLENS(TM) ONE DAY DISPOSABLE (HILAFILCON A) VISIBILITY TINTED CONTACT LENS received FDA 510(k) clearance under submission number K974780, sponsored by Bausch & Lomb, 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 1998-03-11.
- Submission: K974780
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 1998-03-11
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.