510(k) · Cleared
ClearedErchonia PL2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tuco Innovations, Inc. · NHN Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy
Cleared on Jan 17, 2002 after a 161-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 77 later devices descend from it.
- Decided
- Jan 17, 2002
- Review
- 161 days
- Class
- Class II
- Product code
- NHN
- Recalls
- None
- Predicates
- 0
77 later devices descend from it, 5 citing it directly.
- This deviceK012580 Erchonia PL2000Tuco Innovations, Inc. · 2002
- Descendant · cites it directly · 73 of its ownK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- Descendant · 2 generations on · 58 of its ownK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
- Descendant · 3 generations on · 57 of its ownK113097 Laser HelmetTheradome, Inc. · 2012
- Descendant · 4 generations on · 46 of its ownK150613 LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015
- Descendant · 3 generations on · 46 of its ownK122950 Laser HelmetTheradome, Inc. · 2013
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K032816Quantum Light Therapy SystemStargate International, Inc. · 2004 · cites it directly73descendants
- K091496Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010 · 2 generations on58descendants
- K113097Laser HelmetTheradome, Inc. · 2012 · 3 generations on57descendants
- K150613LaserCap LC Pro and LC EliteTransdermal Cap, Inc. · 2015 · 4 generations on46descendants
- K122950Laser HelmetTheradome, Inc. · 2013 · 3 generations on46descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K012580 | Erchonia PL2000 | Tuco Innovations, Inc. | 2002 | — |
| +1 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| +2 | K091496 | Mep-90 Hair Growth Stimulation System | Midwest Rf, LLC | 2010 | — |
| +3 | K113097 | Laser Helmet | Theradome, Inc. | 2012 | — |
| +4 | K150613 | LaserCap LC Pro and LC Elite | Transdermal Cap, Inc. | 2015 | — |
| +3 | K122950 | Laser Helmet | Theradome, Inc. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 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 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 7 | 0 |
| 2026 | 5 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (77)
See all 775 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?
- Of its descendants, K032816 (Stargate International, Inc., 2004) has gone furthest, with 73 descendants of its own.
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 TUCO Erchonia PL2000 is indicated for adjunctive use in providing temporary refief of minor chronic neck and shoulder pain of musculoskeletal origin.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K012580 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012580: Erchonia PL2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012580
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026