Phakosystems CT-100 Cautery Module

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

510(k) Number

K860236 ↗

FDA Product Code

GEI

Device Class

Class II

Regulation

21 CFR Part 878.4400

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

• Phakosystems Model 1000/Omni Packs Irrigation/Aspiration

  Class I

  FDA 510(k) K830871 Active Cleared 2 Jun 1983

• Vision Care/Phakosystems Echopach

  Class II

  FDA 510(k) K880081 Active Cleared 15 Mar 1988

• Vision Care/Phakosystems Echorule

  Class II

  FDA 510(k) K871938 Active Cleared 23 Nov 1987

• Phakosystems Model Ces 4100

  Class II

  FDA 510(k) K851674 Active Cleared 5 Aug 1985

• What types of surgical procedures is the CT-100 Cautery Module primarily used for, and how does it help during those procedures?

  The CT-100 Cautery Module is designed for use in general and plastic surgery procedures. It provides precise control for tissue coagulation and cutting, which helps achieve hemostasis (stopping bleeding) and clean incisions. This makes it useful during surgeries where minimizing blood loss and maintaining tissue integrity are critical, such as in reconstructive or cosmetic plastic surgery, as well as general surgical interventions.

• Is the CT-100 Cautery Module intended for single-use or reusable applications, and what sterilization steps are required?

  The CT-100 Cautery Module is reusable and must undergo standard sterilization protocols before each use. Since it is designed for surgical environments, proper cleaning and sterilization (such as autoclaving or chemical sterilization) are essential to ensure safety and functionality between procedures. Always follow manufacturer guidelines for sterilization to maintain device integrity.

• How do I determine if this device is compatible with my existing surgical setup, and what regulatory pathway was followed for its approval?

  The CT-100 Cautery Module was cleared via the FDA 510(k) traditional review pathway and is classified under product code GEI (General and Plastic Surgery). It is intended for use in controlled surgical environments and is substantially equivalent to a predicate device, meaning it meets established safety and performance standards. Before integration, verify compatibility with your facility’s electrical and surgical systems, as well as adherence to sterilization protocols.

• What should I consider when storing the CT-100 Cautery Module to ensure its longevity and readiness for use?

  Since the CT-100 is a reusable device, it should be stored in a clean, dry, and protected environment to prevent damage or contamination between uses. Avoid exposure to moisture, extreme temperatures, or physical stress. Follow the manufacturer’s storage instructions to maintain functionality, and ensure it is properly cleaned and sterilized before each procedure to comply with surgical best practices.