510(k) · Cleared
ClearedTH0R Ddii IR Lamp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thor Intl. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Mar 17, 2004 after a 90-day review. The FDA summary names its predicate without a number. 109 later devices descend from it.
- Decided
- Mar 17, 2004
- Review
- 90 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 0
109 later devices descend from it, 7 citing it directly.
- This deviceK033923 TH0R Ddii IR Lamp SystemThor Intl. · 2004
- Descendant · cites it directly · 77 of its ownK070024 Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR…Thor International · 2007
- Descendant · 2 generations on · 58 of its ownK083595 EzlaseBiolase Technology, Inc. · 2009
- Descendant · 3 generations on · 31 of its ownK121286 EPIC 10Biolase Technology, Inc. · 2012
- Descendant · 3 generations on · 25 of its ownK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
- Descendant · 2 generations on · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017
Showing 5 of 109 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 109 · See all- K070024Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode ProbeThor International · 2007 · cites it directly77descendants
- K083595EzlaseBiolase Technology, Inc. · 2009 · 2 generations on58descendants
- K121286EPIC 10Biolase Technology, Inc. · 2012 · 3 generations on31descendants
- K123971Cynosure 1064NM Diode LaserCynosure, Inc. · 2013 · 3 generations on25descendants
- K170500SIROLaser Advance+Dentsply Sirona · 2017 · 2 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K033923 | TH0R Ddii IR Lamp System | Thor Intl. | 2004 | — |
| +1 | K070024 | Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode Probe | Thor International | 2007 | — |
| +2 | K083595 | Ezlase | Biolase Technology, Inc. | 2009 | — |
| +3 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| +3 | K123971 | Cynosure 1064NM Diode Laser | Cynosure, Inc. | 2013 | — |
| +2 | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 6 | 0 |
| 2018 | 3 | 0 |
| 2019 | 8 | 0 |
| 2020 | 6 | 0 |
| 2021 | 5 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 7 | 0 |
| 2025 | 13 | 0 |
| 2026 | 10 | 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? (2)
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 |
|---|---|---|---|
| * | — | Super Nova / Acubeam systems Named without a submission number | |
| * | — | BioFlex Professional Therapy System Named without a submission number |
What descends from it? (109)
See all 1097 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070024 | Thor VR Single Diode Laser Treatment Probe, Model 200 MW Single VR Diode Probe | 2007 | 77 |
| K081962 | Lapex BCS | 2008 | 19 |
| K053473 | Maestro MDTL Laser System | 2006 | 8 |
| K052647 | Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155… | 2005 | 2 |
| K082969 | Luminex Infrared Lamp System | 2008 | 1 |
| K060134 | Apollo IR Heat Lamp System | 2006 | 1 |
| K073352 | Weberneedle Basic Laser | 2008 | 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?
- Of its descendants, K070024 (Thor International, 2007) has gone furthest, with 77 descendants of its own.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DDII IR Lamp System is intended to emit energy in the visible and 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 the temporary relaxation of muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033923 · printed Nov 5, 2026
Cite this page
510(k) Report. “K033923: TH0R Ddii IR Lamp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K033923
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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