Clearance Summary
MONARCH II IOL DELIVERY SYSTEM received FDA 510(k) clearance under submission number K001157, sponsored by Alcon Research, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 2000-06-27.
- Submission: K001157
- Applicant / Sponsor: Alcon Research, Ltd.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class I
- Regulation citation: 21 CFR 886.4300
- Decision date: 2000-06-27
Classification & Regulation
This clearance is catalogued under FDA product code KYB and 21 CFR 886.4300, within the Ophthalmic review panel as a Class I device.