# K050070: K-Laser, Models 3,4,4D,6D

- Pathway: 510(k) (Traditional)
- Applicant: Eltech S.R.L
- Decided: Mar 25, 2005 after 72 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 K001179 (2000). 11 ancestors in all.
12 later devices descend from it; 5 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031612: Alt Laser, Model VTR 75, Avicenna Laser Technology, Inc. (2003). Our reading of the summary gave K031613, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ALT Laser, Model VTR 75”. Summary page 2.
- K040662: Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser Systems, Chattanooga Group (2004) Summary page 1.
- K040729: Solaris D890 Therapy Probe, Dynatronics Corp. (2004) Summary page 1.

## Most influential descendants
- K070400: LC Therapy, Model LCT-1000 (2007), 8 descendants of its own
- K091497: K-Laser K-1200, Model 12 W (2009), 7 descendants of its own
- K061656: Laser-D68 (2006), 5 descendants of its own
- K120604: K-Laser (2012), 4 descendants of its own
- K083560: Expanded Spectrum Photo Therapy Device, Model Espt-3X (2008), 1 descendant of its own

## Indications for use
The 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/K050070
Methodology: https://510kreport.com/methodology