510(k) · Cleared
ClearedQuantum Light Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stargate International, Inc. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Mar 26, 2004 as substantially equivalent to K012580 (Tuco Innovations, Inc., 2002) and 2 other predicates after a 199-day review. Its family tree reaches back 2 generations to 2000. 73 later devices descend from it.
- Decided
- Mar 26, 2004
- Review
- 199 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K001179 (2000). 3 ancestors in all. 73 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 1 generation backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- This deviceK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- Descendant · cites it directly · 58 of its ownK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- Descendant · 2 generations on · 57 of its ownK113097 Laser HelmetTheradome, Inc. · 2012
- Descendant · 3 generations on · 46 of its ownK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- Descendant · 2 generations on · 46 of its ownK122950 Laser HelmetTheradome, Inc. · 2013
- Descendant · 4 generations on · 44 of its ownK153618 Capillus202Capillus, LLC · 2016
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K091496Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010 · cites it directly58descendants
- K113097Laser HelmetTheradome, Inc. · 2012 · 2 generations on57descendants
- K150613LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015 · 3 generations on46descendants
- K122950Laser HelmetTheradome, Inc. · 2013 · 2 generations on46descendants
- K153618Capillus202Capillus, LLC · 2016 · 4 generations on44descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −1 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| 0 (this device) | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| +1 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| +2 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| +3 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| +2 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
| +4 | K153618 | Capillus202 | Capillus, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 4 | 0 |
| 2016 | 7 | 0 |
| 2017 | 1 | 0 |
| 2018 | 10 | 0 |
| 2019 | 5 | 0 |
| 2020 | 4 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 5 | 0 |
| 2024 | 8 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 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? (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 | Decided |
|---|---|---|---|
| * | K012580 | Erchonia PL2000Summary page 2…m establishes equivalence to include the following: Prodlcore Qwe 510{~. # 14a~Ktu~ Tuco Erchonia PL3000 .................. K012580 Tuco Innovations Super Nova; Accubean ................. KOO 1179 Light Force Therapy, Inc. MedX 100 Series ..… | 2002 |
| * | K001179 | Super Nova, Acubeam | 2000 |
| * | K020017 | Medx 1000 SeriesSummary page 2…K012580 Tuco Innovations Super Nova; Accubean ................. KOO 1179 Light Force Therapy, Inc. MedX 100 Series ........................... K020017 MedX Electronics, Inc. V.Intended Use of the Device' The Quantum Light Therapy System is a non-heating lamp, in… | 2002 |
What descends from it? (73)
See all 734 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 4 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K091496 (Midwest Rf, LLC, 2010) has gone furthest, with 58 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 Quantum Light Therapy System is a non-heating lamp, infrared as described under the provisions of 21 CFR §890.5500 and is indicated for:
Adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin using the QS-2; QS-4; and/or the QS-L applicator heads.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032816 · printed Nov 4, 2026
Cite this page
510(k) Report. “K032816: Quantum Light Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032816
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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