# K080084: Cell Gen Laser, Model CG-4000

- Pathway: 510(k) (Traditional)
- Applicant: Cell Gen Therapeutics, LLC
- Decided: Apr 21, 2008 after 101 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: 4 generations back to K875052 (1988). 13 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032787: Neurolase, Models 150V, 150C, 1064, Spectrum Laser & Technologies (2003) Summary page 1.

## Most influential descendants
- K213524: CytonPro-5000 (2022), 0 descendants of its own

## Indications for use
The model CG-4000 Cell Gen 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/K080084
Methodology: https://510kreport.com/methodology