# K030275: MB System, Bioenergy Light Therapy

- Pathway: 510(k) (Traditional)
- Applicant: Amest Corp.
- Decided: Nov 29, 2004 after 672 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: 2 generations back to K001179 (2000). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020017: Medx 1000 Series, Medx Electronics, Inc. (2002) Summary page 1.
- K014208: Ssir System, Russian-American Technology Associates, Inc. (2002) Summary page 1.

## Indications for use
The MB System is a device that emits energy in the infrared spectrum to provide temporary increase in local blood circulation, temporary relief of muscle pain, spasms and stiffness, temporary relief of minor pain and joint aches associated with arthritis, and relaxation of muscles.

Source page: https://510kreport.com/device/K030275
Methodology: https://510kreport.com/methodology