# K030226: Thor Ddii 830CL3 Laser System

- Pathway: 510(k) (Traditional)
- Applicant: Thor Intl.
- Decided: Feb 10, 2003 after 19 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: 2 generations back to K010175 (2002). 3 ancestors in all.
6 later devices descend from it; 4 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010175: Microlight 830 Laser System, Microlight Corporation of America (2002) Summary page 1.
- K020657: Acculaser Pro Low Level Laser Therapy Device, Acculaser, Inc. (2002) Summary page 1.
- K021985: Medx LCS Laser Series, Medx Electronics, Inc. (2002) Summary page 1.

## Most influential descendants
- K241057: Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) (2025), 1 descendant of its own
- K034009: LAPEX 2000 (2005), 1 descendant of its own
- K252273: Therapy US (2025), 0 descendants of its own
- K232813: Therapy EC, Therapy XT (2024), 0 descendants of its own
- K203337: PainTB, PainTJ (2022), 0 descendants of its own

## Indications for use
The THOR DDII 830CL3 Laser System is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

Source page: https://510kreport.com/device/K030226
Methodology: https://510kreport.com/methodology