Clearance Summary
FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC received FDA 510(k) clearance under submission number K030593, sponsored by X-Cel Contacts, A Walman Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2003-05-30.
- Submission: K030593
- Applicant / Sponsor: X-Cel Contacts, A Walman Co.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2003-05-30
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.