# K983277: Lightsource or Illuminator Model I-100

- Pathway: 510(k) (Traditional)
- Applicant: Cuda Products Co.
- Decided: Dec 16, 1998 after 90 days
- Product code: HBI (Illuminator, Fiberoptic, Surgical Field)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
To provide light for fiberoptic cables and instruments. Provide light for instrumentation via fiberoptic cables for use in surgical fields. For example: lightsource attaches to fiberoptic cable which is then attached to a headlight or microscope or video camera. The lightsource supplies light for the headlight or microscope or video camera.

Source page: https://510kreport.com/device/K983277
Methodology: https://510kreport.com/methodology