# K041364: ML830 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Microlight Corporation of America
- Decided: Dec 13, 2004 after 206 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: 1 generation back to K022888 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022888: Acubeam, Super Nova, Dio, Light Force Therapy, Inc. (2002) Summary page 1.

## Indications for use
MicroLight Corporation of America's "ML830®d" is an infrared lamp that is indicated for use 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, arthritis and muscle spasm; relieving stiffness; promoting relaxation of muscle tissue; and to temporarily increase local blood circulation where applied.

Source page: https://510kreport.com/device/K041364
Methodology: https://510kreport.com/methodology