510(k) Report

510(k) · Cleared

Cleared

LC Therapy, Model LCT-1000

K070400510(k) TraditionalCleared Feb 28, 200716-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

Litecure, LLC · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Feb 28, 2007 as substantially equivalent to K050070 (Eltech S.R.L, 2005) and 1 other predicate after a 16-day review. Its family tree reaches back 5 generations to 2000. 8 later devices descend from it.

Decided
Feb 28, 2007
Review
16 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
2

Its longest line of descent runs back 5 generations to K001179 (2000). 12 ancestors in all, the oldest K941461 (1995). 8 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2004: 1 other ancestor2000: 1 other ancestor1995: 4 other ancestors2009: 1 descendant cleared2011: 1 descendant cleared2014: 1 descendant cleared2012: 1 descendant cleared2016: 2 descendants cleared2015: 1 descendant cleared2017: 1 descendant 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. · 2004K050070 · K-Laser, Models 3,4,4D,6D · Eltech S.R.L · 20051995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 2 other ancestors4 generations back: 4 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants K050070 · K-Laser, Models 3,4,4D,6D · Eltech S.R.L · 2005K040729 · 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. · 2000−50
  1. Root · 5 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
  2. 4 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
  3. 3 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
  4. 2 generations backK040729 Solaris D890 Therapy ProbeDynatronics Corp. · 2004
  5. 1 generation backK050070 K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005
  6. This deviceK070400 LC Therapy, Model LCT-1000Litecure, LLC · 2007
  7. Descendant · cites it directly · 7 of its ownK091497 K-Laser K-1200, Model 12 WEltech S.R.L · 2009
  8. Descendant · 2 generations on · 4 of its ownK120604 K-LaserEltech S.R.L · 2012
  9. Descendant · 3 generations on · 0 of its ownK171087 AXON IR Heat LampCrystal Medtech, LLC · 2017
  10. Descendant · 3 generations on · 0 of its ownK161198 Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
  11. Descendant · 3 generations on · 0 of its ownK160947 LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR…Usa Laser Biotech, Inc. · 2016

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12012: 12014: 12015: 12016: 22017: 1
2009high 2 (2016) · low 0 (2010)2026

Most influential descendants

Showing 5 of 8 · See all
  • K091497K-Laser K-1200, Model 12 WEltech S.R.L · 2009 · cites it directly7descendants
  • K120604K-LaserEltech S.R.L · 2012 · 2 generations on4descendants
  • K171087AXON IR Heat LampCrystal Medtech, LLC · 2017 · 3 generations on0descendants
  • K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016 · 3 generations on0descendants
  • K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K001179Super Nova, AcubeamLight Force Therapy, Inc.2000—
−4K020017Medx 1000 SeriesMedx Electronics, Inc.2002—
−3K031329Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe…Dynatronics Corp.2003—
−2K040729Solaris D890 Therapy ProbeDynatronics Corp.2004—
−1K050070K-Laser, Models 3,4,4D,6DEltech S.R.L2005—
0 (this device)K070400LC Therapy, Model LCT-1000Litecure, LLC2007—
+1K091497K-Laser K-1200, Model 12 WEltech S.R.L2009—
+2K120604K-LaserEltech S.R.L2012—
+3K171087AXON IR Heat LampCrystal Medtech, LLC2017—
+3K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.2016—
+3K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp…Usa Laser Biotech, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199540
200010
200310
200410

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201210
201410
201510
201620
201710
FIG. 1 — Lineage of K070400, 2000–2017Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K050070K-Laser, Models 3,4,4D,6D
Summary page 1
…____ Classification Infrared Lamp 21 CFR 890.5500 - -__________ Predicate: *K-I aser Therapy Probe -Cleared tinder K050070 market clearncee dlate May 25, 2005 ALTI Laser, Model VTR 75-…
Eltech S.R.L2005—
*K031612Alt Laser, Model VTR 75Avicenna Laser Technology, Inc.2003—

Also cleared against K050070: 4 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K091497K-Laser K-1200, Model 12 WEltech S.R.L20097
K103511Litecure Therapy SystemLitecure, LLC20110

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 7 years and passes through 5 companies; a new generation was cleared every 1.3 years on median.
  • None of the 12 ancestors has a recall.
  • Of its descendants, K091497 (Eltech S.R.L, 2009) has gone furthest, with 7 descendants of its own.
  • 4 other devices also cite its predicate K050070.

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. 2007, this device’s year, is highlighted.

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?

LC Therapy, Model LCT-1000 is indicated for emitting energy in the infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K070400: LC Therapy, Model LCT-1000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070400

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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