# K130866: Biolight Biodynam

- Pathway: 510(k) (Special)
- Applicant: Biolight AB
- Decided: Oct 25, 2013 after 211 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 Biolight Biodynam Device is a portable instrument intended to provide infrared light therapy to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, muscle spasm, relieving stiffness and promoting relaxation of muscle tissue. The Bialight Biodynamn consists of a hand unit with diodes that delivers the light therapy in accordance with pre-programmed treatments.

Source page: https://510kreport.com/device/K130866
Methodology: https://510kreport.com/methodology