IOLAB.SITE CD Phacoemulsification Module

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

510(k) Number

K944993 ↗

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

• 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

• Site Simcoe Style I/a Handpiece

  Class II

  FDA 510(k) K842458 Active Cleared 15 Aug 1984

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• What is the primary purpose of the IOLAB.SITE CD Phacoemulsification Module in cataract surgery?

  The IOLAB.SITE CD Phacoemulsification Module is designed to emulsify and aspirate the lens nucleus during cataract surgery using ultrasonic energy. This process facilitates the removal of the clouded lens, allowing it to be replaced with an intraocular lens (IOL). It integrates with the IOLAB.SITE platform to perform precise phacoemulsification procedures in ophthalmic settings.

• Is the IOLAB.SITE CD Phacoemulsification Module intended for single-use or reusable applications?

  The device is explicitly intended for single-use in sterile surgical environments. This design ensures patient safety and maintains sterility, as reuse could compromise its integrity and introduce infection risks.

• What regulatory pathway was followed for FDA clearance of this device, and what classification does it hold?

  The IOLAB.SITE CD Phacoemulsification Module received FDA 510(k) clearance (K944993) under the HQC product code, following a Traditional 510(k) review. It is classified as a Class II medical device and is regulated under FDA regulation number 886.4670, indicating it requires compliance with specific performance standards and labeling requirements.

• Can this module be used in MRI-safe surgical environments, and how should it be stored to maintain functionality?

  Yes, the IOLAB.SITE CD Phacoemulsification Module is compatible with MRI-safe surgical settings. To maintain sterility and functionality, it must be stored according to manufacturer guidelines—typically in a sealed, sterile packaging until use, away from extreme temperatures, moisture, or contamination.

• Are there multiple models or sizes available for this phacoemulsification module, and how would I identify the correct one for my procedure?

  The provided data lists multiple FEI numbers (e.g., 1000120314, 3006695864), which likely correspond to different model variants or configurations of the IOLAB.SITE CD Phacoemulsification Module. These variations may cater to specific surgical needs (e.g., power settings, probe compatibility, or procedural adjustments). To determine the correct model, consult the manufacturer’s documentation or a surgical specialist, as selection depends on factors like patient anatomy, surgeon preference, and procedural complexity.