# K040664: Omnilight VL-2004, PL-2004, DL-2004, and WL-2004

- Pathway: 510(k) (Traditional)
- Applicant: Omnilight, Inc.
- Decided: May 28, 2004 after 79 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.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The OmniLight VL-3000, PL-3000, DL-3000 and WL-3000 are indicated for emitting 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 pains, minor arthritis pain and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue and to temporarily increase local blood circulation.

Source page: https://510kreport.com/device/K040664
Methodology: https://510kreport.com/methodology