Clearance Summary
MICROPULSE PHACOEMULSIFICATION SYSTEM received FDA 510(k) clearance under submission number K051186, sponsored by Trillium Medical, 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 2005-08-18.
- Submission: K051186
- Applicant / Sponsor: Trillium Medical, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 2005-08-18
Classification & Regulation
This clearance is catalogued under FDA product code HQC and 21 CFR 886.4670, within the Ophthalmic review panel as a Class II device.