# K043317: Omnilux Plus

- Pathway: 510(k) (Traditional)
- Applicant: Photo Therapeutics Limited
- Decided: Mar 15, 2005 after 103 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- 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 K974468 (1998). 5 ancestors in all.
171 later devices descend from it; 10 cite it directly.
0 of 177 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K974468: Photonic Stimulator, Bales Scientific, Inc. (1998) Summary page 1.
- K032229: Quantum Warp 10 Light Delivery System, Quantum Devices, Inc. (2003) Summary page 1.
- K022888: Acubeam, Super Nova, Dio, Light Force Therapy, Inc. (2002) Summary page 1.
- K982546: Phaser-2000, Diomedics, Inc. (1998) Summary page 1.
- K993684: Spinal Pad, Bioscan, Inc. (2000) Summary page 1.

## Most influential descendants
- K050216: Omnilux Revive and Omnilux Plus (2005), 160 descendants of its own
- K060792: Illumimed (2006), 115 descendants of its own
- K083183: Aklarus Phototherapy System (2009), 91 descendants of its own
- K072459: Omnilux New-U (2008), 91 descendants of its own
- K111286: Quasar Calypso (2012), 76 descendants of its own

## Indications for use
The Omnilux Plus is used for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and to temporarily increase local blood circulation where applied.

Source page: https://510kreport.com/device/K043317
Methodology: https://510kreport.com/methodology