Megatron Ophthalmic Surgical System

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

510(k) Number

K961658 ↗

FDA Product Code

HQC

Device Class

Class II

Regulation

21 CFR Part 886.4670

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

• Phacoemulsification Unit to Remove Catarac. Lens

  Class II

  FDA 510(k) K894512 Active Cleared 17 Oct 1989

• Magnetron Munich Model Electronic Control Unit

  Class II

  FDA 510(k) K894511 Active Cleared 17 Oct 1989

• Aspitron

  Class II

  FDA 510(k) K823088 Active Cleared 6 Apr 1983

• Diathron(R) Diathermy Unit

  Class II

  FDA 510(k) K894513 Active Cleared 31 Oct 1989

• (Micro-Keratron, Micro Duct Trephine)

  Class I

  FDA 510(k) K791763 Active Cleared 5 Nov 1979

• What is the primary purpose of the Megatron Ophthalmic Surgical System in cataract surgery?

  The Megatron Ophthalmic Surgical System is designed specifically for phacofragmentation during cataract surgery. It uses ultrasound technology through a fragmenting needle to break down and emulsify cataracts, making it easier to remove them via phacoemulsification techniques. This process helps surgeons efficiently clear clouded lenses while minimizing manual intervention.

• Is the Megatron Ophthalmic Surgical System reusable or single-use, and what does that mean for my facility?

  The Megatron Ophthalmic Surgical System is reusable, meaning it is intended to be sterilized and reused multiple times in clinical settings. This requires adherence to strict surgical sterility protocols to ensure patient safety between uses. Facilities must follow proper cleaning, disinfection, and sterilization procedures as outlined in the manufacturer’s instructions to maintain device integrity and compliance with regulatory standards.

• How many different models or configurations of the Megatron Ophthalmic Surgical System are available?

  The Megatron Ophthalmic Surgical System is listed under multiple FEI (Facility Establishment Information) numbers, indicating it may be available in various configurations or variants (e.g., different needle types, power settings, or accessories). While the exact models aren’t detailed here, the system’s design suggests flexibility for different surgical needs. For precise specifications, refer to the manufacturer’s documentation or contact Intl. Ophthalmic Industries Corp. directly.

• What regulatory pathway was followed for the FDA clearance of this device, and what does that mean for its safety and equivalence?

  The Megatron Ophthalmic Surgical System received a Traditional 510(k) clearance (K961658) under the FDA’s ophthalmic category (product code HQC). This pathway demonstrates that the device was determined to be substantially equivalent to a legally marketed predicate device, meaning it shares the same intended use and technological characteristics. The clearance reflects compliance with FDA standards for safety and effectiveness, though ongoing post-market surveillance may apply. The system is classified as a Class 2 device, indicating moderate regulatory oversight.

• How should the Megatron Ophthalmic Surgical System be stored to maintain its performance and sterility?

  Since the system is reusable, it must be stored in a clean, dry, and protected environment when not in use to prevent contamination or damage. Before sterilization, follow the manufacturer’s guidelines for cleaning and disinfection. After sterilization, store in a sealed, sterile packaging or container until ready for use. Avoid exposure to moisture, extreme temperatures, or physical stress, as these can compromise the device’s integrity or sterility. Always check expiration dates or sterility indicators if applicable.