Clearance Summary
UNIT, PHACOFRAGMENTATION received FDA 510(k) clearance under submission number K103023, sponsored by Abbott 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 2011-06-01.
- Submission: K103023
- Applicant / Sponsor: Abbott Medical Optics, Inc.
- Clearance pathway: Abbreviated
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 2011-06-01
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.