Clearance Summary
Samfilcon B Custom Contact Lens received FDA 510(k) clearance under submission number K230954, sponsored by Bausch + Lomb, Incorporated. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2023-11-17.
- Submission: K230954
- Applicant / Sponsor: Bausch + Lomb, Incorporated
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2023-11-17
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.