Clearance Summary
AIVUS (7000), ASPIRATION AND IRRIGATION DEVICE received FDA 510(k) clearance under submission number K860891, sponsored by Intra-Optics Labs. C/O Newman Assoc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Ophthalmic review panel. The statutory decision date of record is 1986-04-21.
- Submission: K860891
- Applicant / Sponsor: Intra-Optics Labs. C/O Newman Assoc.
- Clearance pathway: Traditional
- Review panel: Ophthalmic
- Device class: Class II
- Regulation citation: 21 CFR 886.4150
- Decision date: 1986-04-21
Classification & Regulation
This clearance is catalogued under FDA product code HQE and 21 CFR 886.4150, within the Ophthalmic review panel as a Class II device.