# K080786: ML830TP

- Pathway: 510(k) (Traditional)
- Applicant: Microlight Corporation of America
- Decided: Oct 3, 2008 after 197 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: 3 generations back to K010175 (2002). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070516: Powerlaser, Powermedic Aps (2007) Summary page 1.
- K030692: Power Laser 90, Andi Electromedical Aps (2003) Summary page 1.
- K070024: Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode Probe, Thor International (2007) Summary page 1.

## Indications for use
MicroLight Corporation of America's ML830®TP is intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and the temporary relaxation of muscles.

Source page: https://510kreport.com/device/K080786
Methodology: https://510kreport.com/methodology