# K252273: Therapy US

- Pathway: 510(k) (Traditional)
- Applicant: Dmc Importação E Exportação DE Equipamentos Ltda
- Decided: Dec 12, 2025 after 143 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: 6 generations back to K001179 (2000). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K241057: Enhanced Handheld Pain Relief Laser Instrument (GD-P-E), Wuhan Guangdun Technology Co.,Ltd.. (2025) Summary page 5.

## Indications for use
Therapy US is generally indicated for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.

Source page: https://510kreport.com/device/K252273
Methodology: https://510kreport.com/methodology