# K050342: Theralase TLC-1000 Therapeutic Medical Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Theralase, Inc.
- Decided: Jul 11, 2005 after 150 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
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K081166: Lightstream Low Level Laser (2009), 0 descendants of its own
- K072551: LD-I 75 and LD-I 200 (2008), 0 descendants of its own

## Indications for use
The Theralase T M TLC-1 000 Therapeutic Medical Laser System is indicated for adjunctive use in the temporary relief of pain associated with knee disorders with standard chiropractic practice.

Source page: https://510kreport.com/device/K050342
Methodology: https://510kreport.com/methodology