# K131226: Novaprobe Led Light Source

- Pathway: 510(k) (Traditional)
- Applicant: Novaprobe Incorporated
- Decided: Jul 24, 2014 after 450 days
- Product code: FCW (Light Source, Fiberoptic, Routine)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K961971 (1996). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082813: Stryker Led Lightsource, Stryker Corp. (2008) Summary page 1.
- K103813: SOPRO 281, Sopro (2011) Summary page 3.
- K121724: Endolight Led 1.1 Endolightled 1.2, Richard Wolf Medical Instruments Corp. (2012) Summary page 1.
- K093792: Led Light Source, Sunoptic Technologies, LLC (2010) Summary page 1.

## Indications for use
The NovaProbe Inc. LED Light is used to illuminate the site of the surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.

Source page: https://510kreport.com/device/K131226
Methodology: https://510kreport.com/methodology