Hi-Light 250 Light Source

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

Full name

The Keymed Hi-Light 250 Light Source

510(k) Number

K864801 ↗

FDA Product Code

GCT

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr

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  FDA 510(k) K881004 Active Cleared 12 May 1988

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• Key-Med Fibrescope Disinfection Trolley

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• Ucs-2, Ultrasonic Cleaning Solution

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• The Keymed Fiberscope Sterilization Case

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  FDA 510(k) K860528 Active Cleared 15 Jul 1986

• The Keymed Vari-Height Patient Couch

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  FDA 510(k) K853421 Active Cleared 19 Sep 1985

See all devices from Keymed, Inc. →

• What is the Keymed Hi-Light 250 Light Source used for?

  The Keymed Hi-Light 250 Light Source is designed specifically for endoscopy procedures, providing high-intensity xenon arc illumination. This ensures optimal visibility of internal tissues and structures during gastrointestinal and urological interventions, aiding both diagnostic and therapeutic tasks.

• Is the Keymed Hi-Light 250 Light Source intended for single-use or reusable applications?

  The device is classified for use in both single-use and reusable applications within clinical settings. This flexibility allows healthcare providers to choose the most suitable option based on their facility’s protocols and infection control practices, while adhering to regulatory standards.

• What are the key regulatory approvals for this light source?

  The Keymed Hi-Light 250 Light Source holds FDA 510(k) clearance under the classification of a Class II device, with the clearance number K864801. It is also categorized under product code GCT, which aligns with its intended use in endoscopy for gastroenterology and urology.

• Does this light source have any specific safety considerations for use in MRI environments?

  The available data does not provide explicit MRI safety information for the Keymed Hi-Light 250 Light Source. Clinicians should consult the manufacturer’s instructions and facility protocols to ensure safe use in MRI environments, particularly if the device contains metallic or non-MRI-compatible components.

• How should the Keymed Hi-Light 250 Light Source be stored?

  While detailed storage instructions are not specified in the provided data, standard medical device regulatory compliance applies. It is recommended to follow the manufacturer’s guidelines for proper storage conditions, such as protecting the device from physical damage, extreme temperatures, and contamination, to maintain its performance and sterility if applicable.