Clearance Summary
Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) received FDA 510(k) clearance under submission number K242059, sponsored by X-Cel Specialty Contacts, A Walman Optical Company. The device was reviewed via the Special premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2024-08-14.
- Submission: K242059
- Applicant / Sponsor: X-Cel Specialty Contacts, A Walman Optical Company
- Clearance pathway: Special
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5925
- Decision date: 2024-08-14
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.