# K062074: Iridex Wireless Footswitch

- Pathway: 510(k) (Traditional)
- Applicant: Iridex Corp
- Decided: Nov 14, 2006 after 116 days
- Product code: HQF (Laser, Ophthalmic)
- Device class: 2
- Regulation: 21 CFR 886.4390
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K931783 (1993). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020374: Oculight SL/SLX, Iridex Corp (2002) Summary page 1.
- K031665: Iris Medical Oculight GL/GLX Laser Systems, Iridex Corp (2003) Summary page 1.
- K050562: Oculight GL/GLX, Iridex Corp (2005) Summary page 1.
- K964074: Diolite 532, Iriderm Div. (1997) Summary page 1.
- K041930: Varilite Laser System, Iridex Corporation (2004) Summary page 1.
- K050453: Odyssey 2.4G, Denlaser Elite, Model 002-00050, Ivoclar Vivadent, Inc. (2005) Summary page 1.
- K033135: Stryker Wireless Universal Footswitch System, Stryker Endoscopy (2004) Summary page 1.
- K053510: IR Wireless Foot Switch, Linemaster Switch Corp. (2006) Summary page 1.
- (no number) IRIDEX Standard Footswitch: named in the summary without a submission number
- (no number) Ivoclar Vivadent Odyssey 2.4G Pedal: named in the summary without a submission number

## Indications for use
The IRIDEX Wireless Footswitch is intended for use with compatible IRIDEX Laser Systems operated in hospital or outpatient facilities. The IRIDEX Wireless Footswitch is indicated for use as an accessory to provide input control of laser emission to compatible IRIDEX Laser Systems. This accessory includes a wireless footswitch and a receiver. It is cleared for use for the particular indications of the laser system to which it is attached

Source page: https://510kreport.com/device/K062074
Methodology: https://510kreport.com/methodology