A O Fiber Optic Illuminator, 1185B

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K821754 ↗

FDA Product Code

FCR

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

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• What clinical specialties is this fiber optic illuminator primarily used in, and why is it designed for those areas?

  This AO Fiber Optic Illuminator 1185B is primarily used in gastroenterology and urology due to its role in providing focused illumination for endoscopic procedures. The device delivers light via fiber optics, which is essential for clearly visualizing internal anatomical structures during examinations like colonoscopies, cystoscopies, or other endoscopic evaluations in these specialties.

• Is this device single-use or reusable, and what maintenance is required to keep it functional?

  The AO Fiber Optic Illuminator 1185B is designed as a reusable instrument. Since it is not sterile by default, it must be cleaned and disinfected after each use following standard medical equipment protocols to maintain functionality and prevent contamination. No additional sterility requirements beyond routine disinfection are specified.

• What power output does this illuminator provide, and how does that affect its use in procedures?

  This device has a 150-watt power output, which ensures a strong, focused light source for endoscopic procedures. The high wattage helps improve visibility of internal structures during examinations, reducing the need for excessive brightness adjustments and minimizing eye strain for both clinicians and patients.

• How is this device regulated, and what does the FDA clearance indicate about its safety and performance?

  The AO Fiber Optic Illuminator 1185B holds an FDA 510(k) clearance (K821754), meaning it has been determined to be substantially equivalent to a legally marketed device in terms of safety and effectiveness. This clearance was granted under the Class II medical device classification (876.1500), indicating it undergoes regulatory oversight to ensure compliance with performance standards for photographic light sources.