# K203337: PainTB, PainTJ

- Pathway: 510(k) (Traditional)
- Applicant: Ptech Co., Ltd.
- Decided: Feb 11, 2022 after 456 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: 3 generations back to K010175 (2002). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K030226: Thor Ddii 830CL3 Laser System, Thor Intl. (2003) Summary page 4.

## Indications for use
Pain TB and Pain TJ Laser systems are indicated for adjunctive use in the temporary relief of low-back pain and wrist pain associated with Carpal Tunnel Syndrome.

Source page: https://510kreport.com/device/K203337
Methodology: https://510kreport.com/methodology