510(k) · Cleared
ClearedMEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medx Electronics, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Oct 3, 2003 as substantially equivalent to K020017 (Medx Electronics, Inc., 2002) after a 74-day review. Its family tree reaches back 2 generations to 2000. 74 later devices descend from it.
- Decided
- Oct 3, 2003
- Review
- 74 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001179 (2000). 74 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 1 generation backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- This deviceK032231 MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx…Medx Electronics, Inc. · 2003
- Descendant · cites it directly · 59 of its ownK082707 Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable LaserMedx Electronics, Inc. · 2008
- 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 · 4 generations on · 21 of its ownK170500 SIROLaser Advance+Dentsply Sirona · 2017
Showing 5 of 74 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 74 · See all- K082707Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable LaserMedx Electronics, Inc. · 2008 · cites it directly59descendants
- 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 · 4 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −1 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| 0 (this device) | K032231 | MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable… | Medx Electronics, Inc. | 2003 | — |
| +1 | K082707 | Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable Laser | Medx Electronics, Inc. | 2008 | — |
| +2 | K083595 | Ezlase | Biolase Technology, Inc. | 2009 | — |
| +3 | K121286 | EPIC 10 | Biolase Technology, Inc. | 2012 | — |
| +3 | K123971 | Cynosure 1064NM Diode Laser | Cynosure, Inc. | 2013 | — |
| +4 | K170500 | SIROLaser Advance+ | Dentsply Sirona | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 9 | 0 |
| 2025 | 11 | 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 |
|---|---|---|---|
| * | K020017 | Medx 1000 SeriesSummary page 2…ain and stiffness associated with arthritis. Technological Characteristics Summary The technological characteristics are based on the predicate device - K020017. Discussion of Non-Clinical and Clinical Data No research was conducted for this specific 510(k)submittal. Conclusions Demon… | 2002 |
What descends from it? (74)
See all 743 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?
- The line of descent spans 3 years and passes through 2 companies; a new generation was cleared every 1.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K082707 (Medx Electronics, Inc., 2008) has gone furthest, with 59 descendants of its own.
- 7 other devices also cite its predicate K020017.
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 MedX 1100 Console and MedX LCT 100 (785 nm) and Duolight 100 (785 run) & 500 Accessories are an infrared lamp system, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis. The MedX LCS 100 Portable Laser (785 nm) is an…
Read the full statement (121 words)
The MedX 1100 Console and MedX LCT 100 (785 nm) and Duolight 100 (785 run) & 500 Accessories are an infrared lamp system, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
The MedX LCS 100 Portable Laser (785 nm) is an infrared lamp, as per 21 CFR 890.5500. The energy emitted provides topical heating for temporary increase in local blood circulation, temporary relief of minor muscle and joint aches, pains and stiffness and relaxation of muscles; for muscle spasms, minor pain and stiffness associated with arthritis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032231 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032231: MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032231
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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