510(k) · Cleared
ClearedLasertouchone (Otc)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laser Health Technologies, LLC · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Apr 15, 2010 as substantially equivalent to K083822 (Laser Health Technologies, LLC, 2009) and 2 other predicates after a 90-day review. Its family tree reaches back 7 generations to 2000.
- Decided
- Apr 15, 2010
- Review
- 90 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 7 generations to K001179 (2000). 23 ancestors in all, the oldest K822854 (1982). No later device cites it as a predicate yet.
- Root · 7 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 6 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 5 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 4 generations backK041530 Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
- 3 generations backK050668 GRT Lite, Model 8-aGrt Solutions, Inc. · 2006
- 2 generations backK081141 Combocare 2000Xanacare Technologies, LLC · 2008
- 1 generation backK083822 Laser TouchoneLaser Health Technologies, LLC · 2009
- This deviceK100116 Lasertouchone (Otc)Laser Health Technologies, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −6 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −5 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −4 | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001 | Stargate International, Inc. | 2004 | — |
| −3 | K050668 | GRT Lite, Model 8-a | Grt Solutions, Inc. | 2006 | — |
| −2 | K081141 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| −1 | K083822 | Laser Touchone | Laser Health Technologies, LLC | 2009 | — |
| 0 (this device) | K100116 | Lasertouchone (Otc) | Laser Health Technologies, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2002 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2009 | 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 NUH? 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 NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 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 |
|---|---|---|---|
| * | K083822 | Laser TouchoneSummary page 1…e use in pain therapy; Names: Transcutaneous electrical nerve stimulator, over-the-counter Product Codes: NH-N; NUH Predicate Devices: K083822, LaserTouchOneim; Laser Health Technologies, LLC K080513; QLaser System; 2035, Inc.… | 2009 |
| * | K080513 | Qlaser SystemSummary page 1…imulator, over-the-counter Product Codes: NH-N; NUH Predicate Devices: K083822, LaserTouchOneim; Laser Health Technologies, LLC K080513; QLaser System; 2035, Inc. K063743; Rhythm Touch Q 2-Way, Shockim Enterprise Ltd. Statement of… | 2009 |
| * | K063743 | Rhythm Touch Q 2-WaySummary page 1…H Predicate Devices: K083822, LaserTouchOneim; Laser Health Technologies, LLC K080513; QLaser System; 2035, Inc. K063743; Rhythm Touch Q 2-Way, Shockim Enterprise Ltd. Statement of The LaserTouchOne~m(OTC) is a low level laser and electri… | 2007 |
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 10 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- None of the 23 ancestors has a recall.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, 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 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
The LaserTouchOne™ (OTC) is a low level laser and electrical stimulation device. This combination of low level light and electrical stimulation provides symptomatic relief of chronic, intractable pain, and is indicated for adjunctive treatment of post-surgical and post-traumatic acute pain and for adjunctive use in providing temporary relief of minor chronic neck and shoulder pain of musculoskeletal origin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100116 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100116: Lasertouchone (Otc).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100116
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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