510(k) · Cleared

Cleared

Trilumina Therapeutic Laser System

K023935510(k) TraditionalCleared Jan 28, 200363-day reviewClass II21 CFR 890.5500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Texas Applied Biomedical Services · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy

Cleared on Jan 28, 2003 as substantially equivalent to K010175 (Microlight Corporation of America, 2002) and 2 other predicates after a 63-day review. Its family tree reaches back 2 generations to 2002.

Decided: Jan 28, 2003
Review: 63 days
Class: Class II
Product code: NHN
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K010175 (2002). 3 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK010175 Microlight 830 Laser SystemMicrolight Corporation of America · 2002
1 generation backK020657 Acculaser Pro Low Level Laser Therapy DeviceAcculaser, Inc. · 2002
This deviceK023935 Trilumina Therapeutic Laser SystemTexas Applied Biomedical Services · 2003

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K010175	Microlight 830 Laser System	Microlight Corporation of America	2002	—
−1	K020657	Acculaser Pro Low Level Laser Therapy Device	Acculaser, Inc.	2002	—
0 (this device)	K023935	Trilumina Therapeutic Laser System	Texas Applied Biomedical Services	2003	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0

FIG. 1 — Lineage of K023935, 2002–2003Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (3)

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	Applicant	Decided	Recalls
*	K010175	Microlight 830 Laser System Summary page 1 …c lasers currently in commercial distribution. These predicate devices include the Microtight Corporation of America, Inc. MicroLight 830 Laser System (K010175), Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657) and the MedX LCS System (K021985). These devices were c…	Microlight Corporation of America	2002	—
*	K020657	Acculaser Pro Low Level Laser Therapy Device Summary page 1 …evices include the Microtight Corporation of America, Inc. MicroLight 830 Laser System (K010175), Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657) and the MedX LCS System (K021985). These devices were cleared for introduction into interstate commerce via the FDA's 5…	Acculaser, Inc.	2002	—
*	K021985	Medx LCS Laser Series Summary page 1 …oration of America, Inc. MicroLight 830 Laser System (K010175), Acculaser, Inc. Acculaser Pro Low Level Laser System (K020657) and the MedX LCS System (K021985). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification proces…	Medx Electronics, Inc.	2002	—

Also cleared against K010175: 10 other devices →

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 1 year and passes through 3 companies; a new generation was cleared every 6 months on median.
None of the 3 ancestors has a recall.
10 other devices also cite its predicate K010175.

How does its category compare?

All NHN devices

NHN 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.

FDA decisions per year · NHN

2in 2025

2007high 3 (2008) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHN

416in 2022

2007high 416 (2022) · low 117 (2018)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NHN

2in 2019

2007high 2 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHN

1in 2025

2007high 1 (2010) · low 0 (2007)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?

The TriLumina Therapeutic Laser System is indicated for adjunctive use in the temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023935 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023935: Trilumina Therapeutic Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023935

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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