# K043306: Skylark Infrared Photon Stimulator, Models, SD-956IR and SD-100IR

- Pathway: 510(k) (Traditional)
- Applicant: Skylark Device & Systems Co., Ltd.
- Decided: Jun 6, 2005 after 187 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
To provide infrared lamp energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles of muscles and relief from pain resulting in improved range of motion.

Source page: https://510kreport.com/device/K043306
Methodology: https://510kreport.com/methodology