# K081166: Lightstream Low Level Laser

- Pathway: 510(k) (Traditional)
- Applicant: Solica Corporation
- Decided: Apr 3, 2009 after 344 days
- Product code: NHN (Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy)
- 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: 1 generation back to K050342 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050342: Theralase TLC-1000 Therapeutic Medical Laser System, Theralase, Inc. (2005) Summary page 2.

## Indications for use
The LightStream Low Level Laser device is intended for adjunct use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.

Source page: https://510kreport.com/device/K081166
Methodology: https://510kreport.com/methodology