# K241057: Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Guangdun Technology Co.,Ltd..
- Decided: Jan 24, 2025 after 281 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: 5 generations back to K001179 (2000). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050668: GRT Lite, Model 8-a, Grt Solutions, Inc. (2006) Summary page 6.
- K012580: Erchonia PL2000, Tuco Innovations, Inc. (2002) Summary page 6.
- K030226: Thor Ddii 830CL3 Laser System, Thor Intl. (2003) Summary page 6.
- K130996: Erchonia Emerge, Erchonia Medical, Inc. (2013) Summary page 6.

## Most influential descendants
- K252273: Therapy US (2025), 0 descendants of its own

## Indications for use
The GD-P-E Enhanced Handheld Pain Relief Laser Instrument generally indicated: - adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin; - adjunctive use in providing temporary relief of minor chronic pain associated with Carpal Tunnel Syndrome (CTS)

Source page: https://510kreport.com/device/K241057
Methodology: https://510kreport.com/methodology