Clearance Summary
LENS PLUS REWETTING DROPS received FDA 510(k) clearance under submission number K042562, sponsored by Advanced Medical Optics, Inc.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2005-07-29.
- Submission: K042562
- Applicant / Sponsor: Advanced Medical Optics, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.5928
- Decision date: 2005-07-29
Classification & Regulation
This clearance is catalogued under FDA product code LPN and 21 CFR 886.5928, within the Ophthalmic review panel as a Class II device.