# K142025: Neurolumen PN-1000

- Pathway: 510(k) (Traditional)
- Applicant: Neurolumen, LLC
- Decided: Jan 21, 2015 after 180 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: 6 generations back to K001179 (2000). 24 ancestors in all.
No later device cites it as a predicate yet.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082223: Neutrolumenpn System, Model 1000, Neurolumen, LLC (2009) Summary page 4.
- K061614: Terraquant MQ2000 V. 5 and Handyrx MQ2007 Lasers, Escada International, Inc. (2006) Summary page 7.
- K071445: Terraquant MQ2000 V.5 with the TQ-1TENS, Escada International, Inc. (2007) Summary page 5.
- K081141: Combocare 2000, Xanacare Technologies, LLC (2008) Summary page 8.

## Indications for use
The Neurolumen is indicated for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated. The Neurolumen is also indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-traumatic acute pain.

Source page: https://510kreport.com/device/K142025
Methodology: https://510kreport.com/methodology