Clearance Summary
NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS received FDA 510(k) clearance under submission number K112192, sponsored by Bausch & Lomb, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2011-10-25.
- Submission: K112192
- Applicant / Sponsor: Bausch & Lomb, Inc.
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2011-10-25
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.