# K110528: Integra Led Surgical Headlight System

- Pathway: 510(k) (Traditional)
- Applicant: Integra LifeSciences Corporation
- Decided: May 11, 2011 after 76 days
- Product code: FSR (Light, Headband, Surgical)
- Device class: 2
- Regulation: 21 CFR 886.4335
- 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 K031548 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031548: Led Headlight, Welch Allyn, Inc. (2003) Summary page 1.

## Indications for use
The Integra Tm LED Surgical Headlight System is designed to provide illumination to aid visualization during minor surgical, diagnostic, or therapeutic procedures.

Source page: https://510kreport.com/device/K110528
Methodology: https://510kreport.com/methodology