Zeiss Superlux High-Intensity Light Sources

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K936198 ↗

FDA Product Code

GCT

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What is the Zeiss Superlux High-Intensity Light Source used for?

  The Zeiss Superlux High-Intensity Light Sources provide illumination for endoscopic and microscopic procedures. They feature a 300W Xenon lamp with near daylight spectrum and a 12V, 100W halogen backup lamp for compatibility with various microscopes and endoscopes.

• How is the Zeiss Superlux light source supplied?

  The device is supplied as a high-intensity light source that requires careful monitoring to prevent thermal damage to skin or tissue. It should be used with moist surfaces and copious irrigation during prolonged procedures.

• What are the specifications of the Zeiss Superlux light source?

  The Zeiss Superlux features a 300W Xenon lamp with a near daylight spectrum and includes a 12V, 100W halogen backup lamp. It is designed for compatibility with various microscopes and endoscopes and requires careful monitoring during use to prevent thermal damage.

• What is the regulatory status of the Zeiss Superlux light source?

  The Zeiss Superlux High-Intensity Light Sources have FDA 510(k) clearance with product code GCT and are classified as a Class II medical device. The clearance was granted on April 6, 1994, with the K number K936198.