# K123177: Stimlase 2000 Low Level Laser Therapy System

- Pathway: 510(k) (Traditional)
- Applicant: Laserstim, Inc.
- Decided: Jul 3, 2013 after 267 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). 29 ancestors in all.
No later device cites it as a predicate yet.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K082969: Luminex Infrared Lamp System, Medical Laser Systems, Inc. (2008) Summary page 3.
- K113017: Sys*Stim 240, Mettler Electronics Corp. (2012)

## Indications for use
The StimLase 2000 System is intended to be used for topical heating of tissue for the purpose of temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasms. The unit may be used for temporary increase in local blood circulation and/or the temporary relaxation of muscles. The StimLase 2000 System is intended to be used for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.

Source page: https://510kreport.com/device/K123177
Methodology: https://510kreport.com/methodology