Clearance Summary
EASY EYES TM CONTACT LENS CLEANING MACHINE received FDA 510(k) clearance under submission number K904824, sponsored by Eaton Medical Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1991-07-05.
- Submission: K904824
- Applicant / Sponsor: Eaton Medical Corp.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 1991-07-05
Classification & Regulation
This clearance is catalogued under FDA product code LYL and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.