510(k) · Cleared
ClearedThor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode Probe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thor International · ILY Lamp, Infrared, Therapeutic Heating
Cleared on May 16, 2007 as substantially equivalent to K033923 (Thor Intl., 2004) after a 133-day review. Its family tree reaches back 1 generation to 2004. 77 later devices descend from it.
- Decided
- May 16, 2007
- Review
- 133 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K033923 (2004). 77 later devices descend from it, 4 citing it directly.
- Root · 1 generation backK033923 TH0R Ddii IR Lamp SystemThor Intl. · 2004
- This deviceK070024 Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR…Thor International · 2007
- Descendant · cites it directly · 58 of its ownK083595 EzlaseBiolase Technology, Inc. · 2009
- Descendant · 2 generations on · 31 of its ownK121286 EPIC 10Biolase Technology, Inc. · 2012
- Descendant · 2 generations on · 25 of its ownK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
- Descendant · cites it directly · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017
- Descendant · 3 generations on · 21 of its ownK150724 SculpSureCynosure, Inc. · 2015
Showing 5 of 77 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 77 · See all- K083595EzlaseBiolase Technology, Inc. · 2009 · cites it directly58descendants
- K121286EPIC 10Biolase Technology, Inc. · 2012 · 2 generations on31descendants
- K123971Cynosure 1064NM Diode LaserCynosure, Inc. · 2013 · 2 generations on25descendants
- K170500SIROLaser Advance+Dentsply Sirona · 2017 · cites it directly21descendants
- K150724SculpSureCynosure, Inc. · 2015 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K033923 | TH0R Ddii IR Lamp System | Thor Intl. | 2004 | — |
| 0 (this device) | K070024 | Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode Probe | Thor International | 2007 | — |
| +1 | K083595 | Ezlase | Biolase Technology, Inc. | 2009 | — |
| +2 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| +2 | K123971 | Cynosure 1064NM Diode Laser | Cynosure, Inc. | 2013 | — |
| +1 | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
| +3 | K150724 | SculpSure | Cynosure, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 4 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 5 | 0 |
| 2017 | 4 | 0 |
| 2018 | 3 | 0 |
| 2019 | 8 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 7 | 0 |
| 2025 | 10 | 0 |
| 2026 | 6 | 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 ILY? 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 ILY device
- #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K033923 | TH0R Ddii IR Lamp SystemSummary page 1…ary relaxation of muscles. IV. Predicate Devices Predicate devices to the THOR VR Diode Probe are the THOR Infrared and Visible Diode Probes (K033923). These devices were cleared for introduction ~nto interstate commerce via the FDA's 510(k) Notification process. V.… | 2004 |
What descends from it? (77)
See all 774 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?
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, 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 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The THOR VR Single Diode Laser Treatment Probe is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or temporary relaxation of muscles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070024 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070024: Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode Probe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070024
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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