# K213524: CytonPro-5000

- Pathway: 510(k) (Traditional)
- Applicant: Cytonsys, Inc.
- Decided: Aug 10, 2022 after 280 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: 5 generations back to K875052 (1988). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080084: Cell Gen Laser, Model CG-4000, Cell Gen Therapeutics, LLC (2008) Summary page 4.

## Indications for use
The model CytonPro-5000 laser emits energy in the infrared spectrum to provide topical heating to elevate tissue temperature for temporary relief of muscle and joint pain, muscle spasm and stiffness associated with arthritis. It also increases blood circulation and relaxes muscle tissue.

Source page: https://510kreport.com/device/K213524
Methodology: https://510kreport.com/methodology