510(k) · Cleared
ClearedPainTB, PainTJ
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ptech Co., Ltd. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Feb 11, 2022 as substantially equivalent to K030226 (Thor Intl., 2003) after a 456-day review. Its family tree reaches back 3 generations to 2002.
- Decided
- Feb 11, 2022
- Review
- 456 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K010175 (2002). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK010175 Microlight 830 Laser SystemMicrolight Corporation of America · 2002
- 2 generations backK020657 Acculaser Pro Low Level Laser Therapy DeviceAcculaser, Inc. · 2002
- 1 generation backK030226 Thor Ddii 830CL3 Laser SystemThor Intl. · 2003
- This deviceK203337 PainTB, PainTJPtech Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K010175 | Microlight 830 Laser System | Microlight Corporation of America | 2002 | — |
| −2 | K020657 | Acculaser Pro Low Level Laser Therapy Device | Acculaser, Inc. | 2002 | — |
| −1 | K030226 | Thor Ddii 830CL3 Laser System | Thor Intl. | 2003 | — |
| 0 (this device) | K203337 | PainTB, PainTJ | Ptech Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in NHN? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new NHN device
- #1 K241057 Enhanced Handheld Pain Relief Laser Instrument…score 12.9 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K030226 | Thor Ddii 830CL3 Laser SystemSummary page 4…ulation number: 21 CFR 890.5500 Product Code: NHN 5. Predicate devices Manufacturer: THØR International Ltd. Brand Name: THØR DDII 830CL3 FDA 510(K) number: K030226 6. Indication for use PainTB and PainTJ Laser systems are indicated for adjunctive use in the temporary relief of low-bac… | 2003 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 20 years and passes through 4 companies; a new generation was cleared every 6 months on median.
- None of the 4 ancestors has a recall.
- 3 other devices also cite its predicate K030226.
How does its category compare?
All NHN devicesNHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · NHN
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHN
416in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHN
2in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHN
1in 2025
MAUDE reports naming product code NHN, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 3 | 260 | 0 | 0 |
| 2009 | 2 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 1 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 3 | 154 | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 3 | 117 | 0 | 0 |
| 2019 | 2 | — | 2 | 1 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 2 | — | 0 | 1 |
| 2022 | 3 | 416 | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 2 | — | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K203337 · printed Nov 4, 2026
Cite this page
510(k) Report. “K203337: PainTB, PainTJ.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K203337
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026