# K051816: Lumiwave 1X4 Infrared Therapy Device

- Pathway: 510(k) (Special)
- Applicant: Biocare Systems, Inc.
- Decided: Aug 26, 2005 after 52 days
- Product code: ILY (Lamp, Infrared, Therapeutic Heating)
- Device class: 2
- Regulation: 21 CFR 890.5500
- 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: 3 generations back to K974468 (1998). 6 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042532: Biocare Systems Premir 818, Biocare Systems, Inc. (2004) Summary page 1.

## Most influential descendants
- K170068: Softcure 96 (2017), 0 descendants of its own
- K142256: Applied BioPhotonics Phototherapy System ABPT1003 (2015), 0 descendants of its own
- K073681: Nanobeam 940, Model 940-900-02 (2008), 0 descendants of its own

## Recalls of this device
- Jun 14, 2006 · Not classified · Z-1419-06: Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electr

## Indications for use
BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief/ reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.

Source page: https://510kreport.com/device/K051816
Methodology: https://510kreport.com/methodology