510(k) · Cleared
ClearedLaser Touchone
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laser Health Technologies, LLC · GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
Cleared on May 6, 2009 as substantially equivalent to K822854 (Rebco Trading Co., 1982) and 3 other predicates after a 135-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it.
- Decided
- May 6, 2009
- Review
- 135 days
- Class
- Class II
- Product code
- GZJ
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K001179 (2000). 19 ancestors in all, the oldest K822854 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 5 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 4 generations backK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
- 3 generations backK041530 Excalibur Light Therapy System, Model Sgiex-04-001Stargate International, Inc. · 2004
- 2 generations backK050668 GRT Lite, Model 8-aGrt Solutions, Inc. · 2006
- 1 generation backK081141 Combocare 2000Xanacare Technologies, LLC · 2008
- This deviceK083822 Laser TouchoneLaser Health Technologies, LLC · 2009
- Descendant · cites it directly · 0 of its ownK100116 Lasertouchone (Otc)Laser Health Technologies, LLC · 2010
Most influential descendants
Showing 1 of 1 · See all- K100116Lasertouchone (Otc)Laser Health Technologies, LLC · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −5 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −4 | K032816 | Quantum Light Therapy System | Stargate International, Inc. | 2004 | — |
| −3 | K041530 | Excalibur Light Therapy System, Model Sgiex-04-001 | Stargate International, Inc. | 2004 | — |
| −2 | K050668 | GRT Lite, Model 8-a | Grt Solutions, Inc. | 2006 | — |
| −1 | K081141 | Combocare 2000 | Xanacare Technologies, LLC | 2008 | — |
| 0 (this device) | K083822 | Laser Touchone | Laser Health Technologies, LLC | 2009 | — |
| +1 | 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 | 1 | 0 |
| 2007 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 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 GZJ? 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 GZJ device
- #1 K252767 actiTENS miniscore 13.1 · 9 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 |
|---|---|---|---|
| * | K822854 | Pro Med 100Summary page 1…in therapy; Names: Transcutaneous electrical nerve stimulator Product Codes: NHN; GZJ Predicate Devices: Rebco Trading Co., Pro Med 100 (K822854) Stargate International, Inc., Quantum Light Therapy System (K03281 6)… | 1982 |
| * | K032816 | Quantum Light Therapy SystemSummary page 1…ate Devices: Rebco Trading Co., Pro Med 100 (K822854) Stargate International, Inc., Quantum Light Therapy System (K03281 6) Xanacare Technologies, Inc., ComnboCare 2000 (K081141) Biomedical Design Instru… | 2004 |
| * | K081141 | Combocare 2000Summary page 1…Stargate International, Inc., Quantum Light Therapy System (K03281 6) Xanacare Technologies, Inc., ComnboCare 2000 (K081141) Biomedical Design Instrumments, Electro-Acuscope 85 (K88391 1) Statement o… | 2008 |
| * | K883911 | Electro-Acuscope 85Summary page 1…Xanacare Technologies, Inc., ComnboCare 2000 (K081141) Biomedical Design Instrumments, Electro-Acuscope 85 (K88391 1) Statement of The LaserTouchOneTm~is a low level laser and electrical Intended Use: stimulation device. T… | 1990 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100116 | Lasertouchone (Otc) | 2010 | 0 |
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 9 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 19 ancestors has a recall.
- Of its descendants, K100116 (Laser Health Technologies, LLC, 2010) has gone furthest, with 0 descendants of its own.
How does its category compare?
All GZJ devicesGZJ Stimulator, Nerve, Transcutaneous, For Pain Relief: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GZJ
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GZJ
207in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GZJ
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · GZJ
13in 2025
MAUDE reports naming product code GZJ, 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 | 13 | 223 | 4 | 4 |
| 2008 | 11 | 136 | 1 | 45 |
| 2009 | 16 | 155 | 0 | 17 |
| 2010 | 5 | 232 | 0 | 22 |
| 2011 | 5 | 168 | 1 | 22 |
| 2012 | 12 | 154 | 0 | 20 |
| 2013 | 2 | — | 0 | 10 |
| 2014 | 4 | 344 | 0 | 23 |
| 2015 | 3 | 202 | 0 | 18 |
| 2016 | 3 | 163 | 0 | 32 |
| 2017 | 3 | 113 | 0 | 58 |
| 2018 | 2 | — | 0 | 21 |
| 2019 | 3 | 156 | 0 | 7 |
| 2020 | 4 | 183 | 0 | 10 |
| 2021 | 3 | 231 | 0 | 5 |
| 2022 | 4 | 175 | 0 | 4 |
| 2023 | 1 | — | 0 | 39 |
| 2024 | 3 | 207 | 0 | 12 |
| 2025 | 1 | — | 0 | 13 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The LaserTouchOneTM 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/K083822 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083822: Laser Touchone.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083822
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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