Iocare Ultrasonic Titanium Tips

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

510(k) Number

K843278 ↗

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 are Iocare Ultrasonic Titanium Tips used for?

  The Iocare Ultrasonic Titanium Tips are ophthalmic devices specifically designed for phacofragmentation during ultrasonic surgical procedures within the eye. They are intended for use in ophthalmic surgical settings to assist in the fragmentation of eye tissue.

• Are these tips single-use or reusable?

  The Iocare Ultrasonic Titanium Tips are supplied as a single-use product. This means they are designed for one surgical procedure only and should not be reused or resterilized for subsequent procedures to ensure patient safety and device performance.

• What is the regulatory status of these ophthalmic tips?

  The Iocare Ultrasonic Titanium Tips are regulated under FDA 510K clearance with product code HQC. They have been determined to be substantially equivalent to other legally marketed devices for phacofragmentation in ophthalmic surgery.

• Who manufactures these ophthalmic devices?

  The Iocare Ultrasonic Titanium Tips are manufactured by Chiron Vision Corp., a company specializing in ophthalmic surgical devices. The company is located in Irvine, California, and has been producing these titanium tips for use in eye surgery procedures.