# K082223: Neutrolumenpn System, Model 1000

- Pathway: 510(k) (Traditional)
- Applicant: Neurolumen, LLC
- Decided: Apr 21, 2009 after 258 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K142025: Neurolumen PN-1000 (2015), 0 descendants of its own

## Indications for use
LED Stimulation for therapeutic heat The NeurolumenPN is indicated for 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 TENS Stimulation 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/K082223
Methodology: https://510kreport.com/methodology