# K120604: K-Laser

- Pathway: 510(k) (Traditional)
- Applicant: Eltech S.R.L
- Decided: May 25, 2012 after 87 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: 7 generations back to K875052 (1988). 30 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091497: K-Laser K-1200, Model 12 W, Eltech S.R.L (2009) Summary page 2.
- K061656: Laser-D68, Laser Pain Clinics LP (2006) Summary page 2.

## Most influential descendants
- K171087: AXON IR Heat Lamp (2017), 0 descendants of its own
- K161198: Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 (2016), 0 descendants of its own
- K160947: LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System LUMIX CPS 5 IR Lamp System (2016), 0 descendants of its own
- K151521: Phoenix Thera-Lase System (2015), 0 descendants of its own

## Indications for use
Each device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

Source page: https://510kreport.com/device/K120604
Methodology: https://510kreport.com/methodology