Clearance Summary
PHACO TIP received FDA 510(k) clearance under submission number K914229, sponsored by Tri-Star Ophthalmic. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1991-12-27.
- Submission: K914229
- Applicant / Sponsor: Tri-Star Ophthalmic
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4670
- Decision date: 1991-12-27
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.