Clearance Summary
GELFLEX DELTA SOFT CONTACT LENS MATERIAL METHAFILCON A 55% WATER CONTENT CLEAR OR BLUE VISITINT, GELFLEX ALPHA SOFT CONT received FDA 510(k) clearance under submission number K024003, sponsored by Gelflex. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2003-02-05.
- Submission: K024003
- Applicant / Sponsor: Gelflex
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2003-02-05
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.