Medigroup LG-102 Light Guide

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

510(k) Number

K823293 ↗

FDA Product Code

HET

Device Class

Class II

Regulation

21 CFR Part 884.1720

Advisory Committee

Obstetrics/Gynecology

FDA Decision

SESE Substantially Equivalent

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See all devices from Medigroup →

• What is the Medigroup LG-102 Light Guide used for?

  The Medigroup LG-102 Light Guide is a gynecologic accessory designed specifically for laparoscopic procedures. It provides targeted illumination within the pelvic cavity, which significantly improves visualization during minimally invasive surgeries in obstetrics and gynecology. This enhanced clarity helps surgeons perform procedures with greater precision, reducing potential complications.

• Is the Medigroup LG-102 Light Guide intended for single-use or reusable applications?

  The regulatory data for the Medigroup LG-102 Light Guide does not specify whether it is intended for single-use or reusable applications. However, like many surgical accessories, its use typically follows standard protocols for either single-use or reusable devices in sterile surgical settings. Clinicians should consult manufacturer guidelines and facility protocols to determine the appropriate handling and reprocessing procedures.

• What are the key specifications or distinguishing features of the Medigroup LG-102 Light Guide?

  The Medigroup LG-102 Light Guide is classified under gynecologic laparoscopes and their accessories, with a focus on providing illumination for pelvic cavity visualization. It is regulated under the FDA 510(k) clearance pathway as substantially equivalent to prior devices. The device is intended for use in sterile surgical environments and is categorized under the product code HET, which aligns with gynecologic surgical instruments. No specific MRI safety or storage conditions are noted in the regulatory data.

• How is the Medigroup LG-102 Light Guide authorized for use?

  The Medigroup LG-102 Light Guide holds FDA 510(k) clearance with the designation K823293. This clearance indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device, meeting regulatory requirements for safety and effectiveness in its intended use for gynecologic laparoscopic procedures. The authorization was granted under the traditional 510(k) review process.

• Are there any special handling or storage instructions for the Medigroup LG-102 Light Guide?

  The regulatory data for the Medigroup LG-102 Light Guide does not provide explicit special handling or storage instructions. However, as with most surgical instruments, it should be stored in a clean, dry environment to maintain sterility and functionality. If reusable, it must undergo proper reprocessing according to established protocols to ensure safety and efficacy. Always follow manufacturer recommendations and facility guidelines for optimal use.