510(k) · Cleared
ClearedGRT Lite, Model 8-a
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Grt Solutions, Inc. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Feb 3, 2006 as substantially equivalent to K012580 (Tuco Innovations, Inc., 2002) and 3 other predicates after a 325-day review. Its family tree reaches back 4 generations to 2000. 9 later devices descend from it.
- Decided
- Feb 3, 2006
- Review
- 325 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K001179 (2000). 7 ancestors in all. 9 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 3 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 2 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 1 generation backK041530 Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
- This deviceK050668 GRT Lite, Model 8-aGrt Solutions, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK081141 Combocare 2000Xanacare Technologies, LLC · 2008
- Descendant · 2 generations on · 2 of its ownK083202 Combocare 2000Xanacare Technologies, LLC · 2008
- Descendant · cites it directly · 1 of its ownK241057 Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd.. · 2025
- Descendant · 2 generations on · 1 of its ownK083822 Laser TouchoneLaser Health Technologies, LLC · 2009
- Descendant · 2 generations on · 0 of its ownK252273 Therapy USDmc Importação E Exportação DE Equipamentos Ltda · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K081141Combocare 2000Xanacare Technologies, LLC · 2008 · cites it directly6descendants
- K083202Combocare 2000Xanacare Technologies, LLC · 2008 · 2 generations on2descendants
- K241057Enhanced Handheld Pain Relief Laser Instrument (GD-P-E)Wuhan Guangdun Technology Co.,Ltd.. · 2025 · cites it directly1descendant
- K083822Laser TouchoneLaser Health Technologies, LLC · 2009 · 2 generations on1descendant
- K252273Therapy USDmc Importação E Exportação DE Equipamentos Ltda · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −3 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −2 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −1 | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001 | Stargate International, Inc. | 2004 | — |
| 0 (this device) | K050668 | GRT Lite, Model 8-a | Grt Solutions, Inc. | 2006 | — |
| +1 | K081141 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| +2 | K083202 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| +1 | K241057 | Enhanced Handheld Pain Relief Laser Instrument (GD-P-E) | Wuhan Guangdun Technology Co.,Ltd.. | 2025 | — |
| +2 | K083822 | Laser Touchone | Laser Health Technologies, LLC | 2009 | — |
| +2 | K252273 | Therapy US | Dmc Importação E Exportação DE Equipamentos Ltda | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2025 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K012580 | Erchonia PL2000Summary page 2…A establishes equivalence to include: Predicate Device 51O(kI # Manufacturer Tuco Erchonia PL3000 .................. K012580 Tuco Innovations Excalibur System ........................... K041530 Stargate International, Inc.… | 2002 |
| * | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001Summary page 2…51O(kI # Manufacturer Tuco Erchonia PL3000 .................. K012580 Tuco Innovations Excalibur System ........................... K041530 Stargate International, Inc. Microlight 830 Laser ..................... K010175 Microlight Corp… | 2004 |
| * | K010175 | Microlight 830 Laser SystemSummary page 2…Tuco Innovations Excalibur System ........................... K041530 Stargate International, Inc. Microlight 830 Laser ..................... K010175 Microlight Corporation of America Acculaser Pro LLLT Device .......... K020657 Acculaser,… | 2002 |
| * | K020657 | Acculaser Pro Low Level Laser Therapy DeviceSummary page 2…nternational, Inc. Microlight 830 Laser ..................... K010175 Microlight Corporation of America Acculaser Pro LLLT Device .......... K020657 Acculaser, Inc. V.Intended Use of the Device The GRT LITE Model PRO-8A is a non-heating lamp, infrared a… | 2002 |
What descends from it? (9)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K081141 (Xanacare Technologies, LLC, 2008) has gone furthest, with 6 descendants of its own.
- 4 other devices also cite its predicate K012580.
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.
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?
The GRT Model PRO-8A is a non-heating lamp, infrared under the provisions of 21 CFR §890.5500 and its indications for use:
Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Adjunctive use in providing temporary relief of hand and wrist pain associated with Carpal Tunnel Syndrome (CTS).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050668 · printed Nov 3, 2026
Cite this page
510(k) Report. “K050668: GRT Lite, Model 8-a.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K050668
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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