Iocare Irrigation/Aspiration Pack

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K843275 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Iocare Converter Kit

  Class II

  FDA 510(k) K843276 Active Cleared 9 May 1985

• Microscope Mitts Support Tray Cover

  Class II

  FDA 510(k) K842859 Active Cleared 5 Oct 1984

• Optical Zone/Hexagonal/Astigmatism/Radial Markers

  Class I

  FDA 510(k) K925606 Active Cleared 29 Aug 1994

• IOLAB.SITE CD Phacoemulsification Module

  Class II

  FDA 510(k) K944993 Active Cleared 12 Oct 1995

• Passport Foldable Lens Placement System

  Class I

  FDA 510(k) K951292 Active Cleared 2 Jun 1995

• Iocare Irrigation & Aspiration Pack

  Class II

  FDA 510(k) K834340 Active Cleared 5 Apr 1984

See all devices from Chiron Vision Corp. →

• What is the Iocare Irrigation/Aspiration Pack used for?

  The Iocare Irrigation/Aspiration Pack is an ophthalmic device designed for use in ophthalmic procedures to perform irrigation and aspiration functions, specifically classified as a Unit for Phacofragmentation.

• Is the Iocare Irrigation/Aspiration Pack reusable or single-use?

  The Iocare Irrigation/Aspiration Pack is intended for single-use only and should not be reused for any ophthalmic procedures to ensure patient safety and device performance.

• What is the regulatory status of the Iocare Irrigation/Aspiration Pack?

  The Iocare Irrigation/Aspiration Pack is FDA 510(k) cleared with product code HQC and regulation number 886.4670, classified as Class II, and reviewed by the Ophthalmic panel.

• How is the Iocare Irrigation/Aspiration Pack supplied?

  The Iocare Irrigation/Aspiration Pack is supplied as a complete pack containing all necessary components for irrigation and aspiration functions in ophthalmic procedures.