# K062635: MODEL 2200

- Pathway: 510(k) (Traditional)
- Applicant: Clarimedex, Inc.
- Decided: Dec 19, 2006 after 104 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 K974468 (1998). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032229: Quantum Warp 10 Light Delivery System, Quantum Devices, Inc. (2003) Summary page 3.
- K931261: Spectropad System, Smi (1994) Summary page 3.

## Indications for use
The CLARIMEDIX device 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 blood circulation where applied.

Source page: https://510kreport.com/device/K062635
Methodology: https://510kreport.com/methodology