# K052814: Lumina 1600, 3300 and 6600 Systems

- Pathway: 510(k) (Traditional)
- Applicant: Usa Laser Biotech, Inc.
- Decided: Nov 30, 2005 after 57 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 K001179 (2000). 4 ancestors in all.
8 later devices descend from it; 3 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031612: Alt Laser, Model VTR 75, Avicenna Laser Technology, Inc. (2003) Summary page 1.
- K001179: Super Nova, Acubeam, Light Force Therapy, Inc. (2000) Summary page 1.
- K023621: Bioflex Professional Therapy System, Meditech International, Inc. (2003) Summary page 1.

## Most influential descendants
- K091726: Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980 (2009), 6 descendants of its own
- K101893: Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus Biowave 30W Pro IR Lamp System, Nexus (2011), 5 descendants of its own
- K171087: AXON IR Heat Lamp (2017), 0 descendants of its own
- K161198: Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 (2016), 0 descendants of its own
- K160947: LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System (2016), 0 descendants of its own

## Indications for use
The LUMINA Systems, as listed above, are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Source page: https://510kreport.com/device/K052814
Methodology: https://510kreport.com/methodology