# K100395: Harmony Vled Surgical Lightning System

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Mar 17, 2010 after 29 days
- Product code: FST (Light, Surgical, Fiberoptic)
- Device class: 2
- Regulation: 21 CFR 878.4580
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K965130 (1997). 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)
- K072072: Harmony Led-1 Surgical Lighting System, STERIS Corporation (2007) Summary page 2.

## Recalls of this device
- Nov 26, 2014 · Class II · Z-0930-2015: STERIS has learned that groups of LED lights (modules) contained within the vLED light head may illuminate inconsistently.

## Indications for use
The Harmony vLED Surgical Lighting System is a variable pattern / intensity surgical light designed to provide visible illumination of the surgical field and the patient and to provide video-visual procedural support for the hospital staff during surgical procedures.

Source page: https://510kreport.com/device/K100395
Methodology: https://510kreport.com/methodology