# K051505: SCB/Steris or-Light Interface Box

- Pathway: 510(k) (Traditional)
- Applicant: KARL STORZ Endoscopy-America, Inc.
- Decided: Aug 11, 2005 after 65 days
- Product code: FTA (Light, Surgical, Accessories)
- 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
Longest line of descent: 1 generation back to K041912 (2004). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041912: SCB/Valleylab Force FX Interface Unit, KARL STORZ Endoscopy-America, Inc. (2004) Summary page 1.

## Most influential descendants
- K081698: Mainstream or Surgical Light Control (MSLC) (2008), 3 descendants of its own
- K102791: Easysuite Surgical Light Control (Eslc) (2010), 2 descendants of its own
- K133413: Idss SLC (2014), 0 descendants of its own
- K112133: Oasys Surgical Light Controller (2012), 0 descendants of its own

## Indications for use
The Storz Communication Bus/STERIS OR-Light Interface device is an interface box that is use to connect the Karl Storz's SCB computer and the STERIS Harmony LA OR-Lighting Control System. This interface box allows SCB computer to control/monitor the STERIS Harmony LA Surgical Lighting System, a room camera and various ambient light settings. It contains software to display the STEMIS Harmony LA OR-Lighting System's control parameter on a SCB computer screen. The interface box software does not perform calculations. It only relays STERIS Harmony LA Surgical Lighting System functions and controls on the SCB computer monitor for the surgeon's convenient control. The safety features of Harmony LA system will remain intact and take precedence over the SCB controls.

Source page: https://510kreport.com/device/K051505
Methodology: https://510kreport.com/methodology