Clearance Summary
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS received FDA 510(k) clearance under submission number K141280, sponsored by Seinoh Optical Co. , Ltd.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2014-07-18.
- Submission: K141280
- Applicant / Sponsor: Seinoh Optical Co. , Ltd.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2014-07-18
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.