Clearance Summary
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL received FDA 510(k) clearance under submission number K100443, sponsored by X-Cel Contacts, 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 2010-10-28.
- Submission: K100443
- Applicant / Sponsor: X-Cel Contacts, Inc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2010-10-28
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.