Modified Site Fiber Optic Module

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

510(k) Number

K924198 ↗

FDA Product Code

FCT

Device Class

Class II

Regulation

21 CFR Part 886.4335

Advisory Committee

Ophthalmic

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K842859 Active Cleared 5 Oct 1984

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  FDA 510(k) K834340 Active Cleared 5 Apr 1984

See all devices from Chiron Vision Corp. →

• What is the Modified Site Fiber Optic Module used for?

  The Modified Site Fiber Optic Module is a fiber optic focusing headlight intended for use in ophthalmic procedures, providing illumination and focus during eye surgeries or examinations as part of the ophthalmic medical specialty.

• Is the Modified Site Fiber Optic Module reusable or single-use?

  The device is supplied as a single-use item and is not reusable, meaning it is intended for one procedure only and should be discarded after use to prevent cross-contamination and ensure optimal performance.

• How is the Modified Site Fiber Optic Module supplied and what are its storage requirements?

  The device is supplied as a single-use sterile unit; while specific storage conditions are not detailed in the provided data, single-use medical devices are typically stored in a cool, dry place away from direct sunlight and extreme temperatures to maintain sterility and integrity until use.

• What regulatory clearance does the Modified Site Fiber Optic Module have?

  The device is regulated under FDA 510(k) clearance with the K number K924198, indicating it was found substantially equivalent to a legally marketed predicate device through a traditional 510(k) submission process.