# K093792: Led Light Source

- Pathway: 510(k) (Traditional)
- Applicant: Sunoptic Technologies, LLC
- Decided: Mar 18, 2010 after 98 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: 2 generations back to K961971 (1996). 2 ancestors in all.
6 later devices descend from it; 4 cite it directly.
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.

## Most influential descendants
- K102167: LO-50 Led Light Source (2010), 3 descendants of its own
- K123359: OVS1 Video System (2012), 1 descendant of its own
- K121724: Endolight Led 1.1 Endolightled 1.2 (2012), 1 descendant of its own
- K103813: SOPRO 281 (2011), 1 descendant of its own
- K152513: 8X-10-XXXX Camera System (2015), 0 descendants of its own

## Indications for use
The LED Light Source is used to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in Endloscopy (general, gastroenterological and ENT surgery). The light is transmitted from the light source through a fiber optic cable and a scope.

Source page: https://510kreport.com/device/K093792
Methodology: https://510kreport.com/methodology