# K041679: Cold Light; Cold Light MD; Gossamer Dermlight

- Pathway: 510(k) (Abbreviated)
- Applicant: Onyx Medical, Inc.
- Decided: Dec 16, 2004 after 178 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. The FDA summary names no predicate by number.

## Indications for use
The Cold Light, Cold Light MD, and Gossamer DermLight are indicated for use as follows: To provide topical heating for the temporary rellef of minor muscle and joint pains and stiffness, the temporary relief of minor joint pain assoclated with arthritls, the temporary Increase In local blood clrculation where applied, the relaxation of muscles, and help muscle spasms, minor spralns and strains, and minor muscular back pain.

Source page: https://510kreport.com/device/K041679
Methodology: https://510kreport.com/methodology