510(k) Report

510(k) · Cleared

Cleared

Laser Sys*Stim 540, Model ME 540

K043586510(k) AbbreviatedCleared May 6, 2005129-day reviewClass II21 CFR 890.5500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Mettler Electronics Corp. · ILY Lamp, Infrared, Therapeutic Heating

Cleared on May 6, 2005 as substantially equivalent to K032231 (Medx Electronics, Inc., 2003) and 2 other predicates after a 129-day review. Its family tree reaches back 4 generations to 2000. 13 later devices descend from it.

Decided
May 6, 2005
Review
129 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
3

Its longest line of descent runs back 4 generations to K001179 (2000). 9 ancestors in all, the oldest K941461 (1995). 13 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor1995: 4 other ancestors2012: 1 descendant cleared2005: 1 descendant cleared2006: 1 descendant cleared2013: 1 descendant cleared2023: 2 descendants cleared2015: 1 descendant cleared2026: 1 descendant cleared2024: 2 descendants cleared2025: 3 descendants clearedK001179 · Super Nova, Acubeam · Light Force Therapy, Inc. · 2000K020017 · Medx 1000 Series · Medx Electronics, Inc. · 2002K031329 · Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional Accessory) · Dynatronics Corp. · 2003K040729 · Solaris D890 Therapy Probe · Dynatronics Corp. · 20041995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 4 descendants3 generations forward: 3 descendants4 generations forward: 2 descendants5 generations forward: 1 descendant6 generations forward: 1 descendant K040729 · Solaris D890 Therapy Probe · Dynatronics Corp. · 2004K031329 · Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional Accessory) · Dynatronics Corp. · 2003K020017 · Medx 1000 Series · Medx Electronics, Inc. · 2002K001179 · Super Nova, Acubeam · Light Force Therapy, Inc. · 20000+5
  1. Root · 4 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
  2. 3 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
  3. 2 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
  4. 1 generation backK040729 Solaris D890 Therapy ProbeDynatronics Corp. · 2004
  5. This deviceK043586 Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp. · 2005
  6. Descendant · cites it directly · 9 of its ownK113017 Sys*Stim 240Mettler Electronics Corp. · 2012
  7. Descendant · 2 generations on · 5 of its ownK223802 accufitMettler Electronics Corporation · 2023
  8. Descendant · 3 generations on · 4 of its ownK233926 accufitMettler Electronics Corporation · 2024
  9. Descendant · 4 generations on · 2 of its ownK241685 SofWave SystemSofwave Medical, Ltd. · 2024
  10. Descendant · cites it directly · 2 of its ownK052647 Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300…American Spine Center, Ltd. · 2005

Showing 5 of 13 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12012: 12013: 12015: 12023: 22024: 22025: 32026: 1
2005high 3 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 13 · See all
  • K113017Sys*Stim 240Mettler Electronics Corp. · 2012 · cites it directly9descendants
  • K223802accufitMettler Electronics Corporation · 2023 · 2 generations on5descendants
  • K233926accufitMettler Electronics Corporation · 2024 · 3 generations on4descendants
  • K241685SofWave SystemSofwave Medical, Ltd. · 2024 · 4 generations on2descendants
  • K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd. · 2005 · cites it directly2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K001179Super Nova, AcubeamLight Force Therapy, Inc.2000—
−3K020017Medx 1000 SeriesMedx Electronics, Inc.2002—
−2K031329Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe…Dynatronics Corp.2003—
−1K040729Solaris D890 Therapy ProbeDynatronics Corp.2004—
0 (this device)K043586Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp.2005—
+1K113017Sys*Stim 240Mettler Electronics Corp.2012—
+2K223802accufitMettler Electronics Corporation2023—
+3K233926accufitMettler Electronics Corporation2024—
+4K241685SofWave SystemSofwave Medical, Ltd.2024—
+1K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275…American Spine Center, Ltd.2005—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199540
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
201210
201310
201510
202320
202420
202530
202610
FIG. 1 — Lineage of K043586, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K032231MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable Laser
Summary page 1
…tially equivalent to other infrared therapeutic lamps that are currently in commercial distribution. These predicate devices include the MedX 1100 Console (K03223 1), Dynatronics' Solaris D890 Therapy Probe (K040729) and Dynatronics' Solaris D880 Infrared Probe (K03 1329). Desc…
Medx Electronics, Inc.2003—
*K040729Solaris D890 Therapy Probe
Summary page 1
…s that are currently in commercial distribution. These predicate devices include the MedX 1100 Console (K03223 1), Dynatronics' Solaris D890 Therapy Probe (K040729) and Dynatronics' Solaris D880 Infrared Probe (K03 1329). Description of Device: The Laser Sys*Stim 540, Model M…
Dynatronics Corp.2004—
*K031329Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…
Summary page 1
…predicate devices include the MedX 1100 Console (K03223 1), Dynatronics' Solaris D890 Therapy Probe (K040729) and Dynatronics' Solaris D880 Infrared Probe (K03 1329). Description of Device: The Laser Sys*Stim 540, Model ME 540, is a portable, AC and battery operated non-invasi…
Dynatronics Corp.2003—

Also cleared against K032231: 2 other devices →

What descends from it? (13)

See all 13

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K113017Sys*Stim 240Mettler Electronics Corp.20129
K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…American Spine Center, Ltd.20052

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 5 years and passes through 4 companies; a new generation was cleared every 1.3 years on median.
  • None of the 9 ancestors has a recall.
  • Of its descendants, K113017 (Mettler Electronics Corp., 2012) has gone furthest, with 9 descendants of its own.
  • 2 other devices also cite its predicate K032231.

How does its category compare?

All ILY devices

ILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ILY

1in 2025

2007: 102008: 162009: 132010: 82011: 92012: 112013: 92014: 112015: 112016: 82017: 52020: 12022: 22023: 12024: 12025: 12026 (partial year): 1
2007high 16 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILY

116in 2017

2007: 128 days median2008: 165 days median2009: 189 days median2010: 185 days median2011: 198 days median2012: 130 days median2013: 211 days median2014: 153 days median2015: 146 days median2016: 214 days median2017: 116 days median
2007high 214 (2016) · low 116 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ILY

1in 2025

2010: 12012: 32022: 42023: 12025: 12026 (partial year): 1
2007high 4 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ILY

17in 2025

2007: 242008: 202009: 92010: 72011: 102012: 72013: 82015: 22016: 22017: 122018: 12019: 72020: 52021: 52022: 22023: 152024: 192025: 17
2007high 24 (2007) · low 0 (2014)2025

MAUDE reports naming product code ILY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200710128024
200816165020
20091318909
2010818517
20119198010
20121113037
2013921108
20141115300
20151114602
2016821402
20175116012
20180—01
20190—07
20201—05
20210—05
20222—42
20231—115
20241—019
20251—117
20261—1—

What is it indicated for?

The Laser Sys*Stim 540, Model ME 540, 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 promoting relaxation of muscles.

Indications for use as stated in the FDA summary.

Also cleared against K032231

2 other devices cite the same predicate.

  • K082707Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable LaserMedx Electronics, Inc. · 2008
  • K052647Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-Base…American Spine Center, Ltd. · 2005

More from Mettler Electronics Corp.

32 FDA decisions under this applicant name. See the company

  • K113017Sys*Stim 240Mettler Electronics Corp. · 2012
  • K111482Sonicator Plus 920Mettler Electronics Corp. · 2011
  • K091540MTD 4000Mettler Electronics Corp. · 20091 recall
  • K071137Sonicator Plus 940, Model ME940Mettler Electronics Corp. · 2007
  • K053546Sonicator 740, Model ME 740Mettler Electronics Corp. · 2006

Recent decisions in ILY

The ILY category page

  • K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight…Wuhan PHOMED Technology Company, Ltd. · 2026
  • K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company, Ltd. · 2025
  • K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc. · 2024
  • K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V. · 2023
  • K221189Oliz LTB-1000ALtbio Co., Ltd. · 2022

https://510kreport.com/device/K043586 · printed Nov 4, 2026

Cite this page

510(k) Report. “K043586: Laser Sys*Stim 540, Model ME 540.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K043586

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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