510(k) · Cleared

Cleared

K-Laser, Models 3,4,4D,6D

K050070510(k) TraditionalCleared Mar 25, 200572-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

Eltech S.R.L · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Mar 25, 2005 as substantially equivalent to K031612 (Avicenna Laser Technology, Inc., 2003) and 2 other predicates after a 72-day review. Its family tree reaches back 4 generations to 2000. 12 later devices descend from it.

Decided: Mar 25, 2005
Review: 72 days
Class: Class II
Product code: ILY
Recalls: None
Predicates: 3

Its longest line of descent runs back 4 generations to K001179 (2000). 11 ancestors in all, the oldest K941461 (1995). 12 later devices descend from it, 5 citing it directly.

By dateBy generation

Root · 4 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
3 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
2 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
1 generation backK040729 Solaris D890 Therapy ProbeDynatronics Corp. · 2004
This deviceK050070 K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005
Descendant · cites it directly · 8 of its ownK070400 LC Therapy, Model LCT-1000Litecure, LLC · 2007
Descendant · cites it directly · 7 of its ownK091497 K-Laser K-1200, Model 12 WEltech S.R.L · 2009
Descendant · cites it directly · 5 of its ownK061656 Laser-D68Laser Pain Clinics LP · 2006
Descendant · 2 generations on · 4 of its ownK120604 K-LaserEltech S.R.L · 2012
Descendant · cites it directly · 1 of its ownK083560 Expanded Spectrum Photo Therapy Device, Model Espt-3XLighthouse Technical Innovations, Inc. · 2008

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2006high 2 (2014) · low 0 (2010)2026

Most influential descendants

Showing 5 of 12 · See all

K070400LC Therapy, Model LCT-1000Litecure, LLC · 2007 · cites it directly8descendants
K091497K-Laser K-1200, Model 12 WEltech S.R.L · 2009 · cites it directly7descendants
K061656Laser-D68Laser Pain Clinics LP · 2006 · cites it directly5descendants
K120604K-LaserEltech S.R.L · 2012 · 2 generations on4descendants
K083560Expanded Spectrum Photo Therapy Device, Model Espt-3XLighthouse Technical Innovations, Inc. · 2008 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−4	K001179	Super Nova, Acubeam	Light Force Therapy, Inc.	2000	—
−3	K020017	Medx 1000 Series	Medx Electronics, Inc.	2002	—
−2	K031329	Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe…	Dynatronics Corp.	2003	—
−1	K040729	Solaris D890 Therapy Probe	Dynatronics Corp.	2004	—
0 (this device)	K050070	K-Laser, Models 3,4,4D,6D	Eltech S.R.L	2005	—
+1	K070400	LC Therapy, Model LCT-1000	Litecure, LLC	2007	—
+1	K091497	K-Laser K-1200, Model 12 W	Eltech S.R.L	2009	—
+1	K061656	Laser-D68	Laser Pain Clinics LP	2006	—
+2	K120604	K-Laser	Eltech S.R.L	2012	—
+1	K083560	Expanded Spectrum Photo Therapy Device, Model Espt-3X	Lighthouse Technical Innovations, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	4	0
2000	1	0
2003	1	0
2004	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2007	1	0
2008	1	0
2009	1	0
2011	1	0
2012	1	0
2014	2	0
2015	1	0
2016	2	0
2017	1	0

FIG. 1 — Lineage of K050070, 2000–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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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.

Type	Number	Device	Applicant	Decided	Recalls
*	K031612	Alt Laser, Model VTR 75 Our reading of the summary gave K031613, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “ALT Laser, Model VTR 75”.	Avicenna Laser Technology, Inc.	2003	—
*	K040662	Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser… Summary page 1 …2. PREDICATE DEVICES: ALT Laser, Model VTR 75 - Cleared under K031613 Vectra Genisys Laser System - Cleared under K 040662 Solaris D890 - Cleared under K040729 3. PERFORMANCE STANDARDS: Klaser conforms to the applicable req…	Chattanooga Group	2004	—
*	K040729	Solaris D890 Therapy Probe Summary page 1 …odel VTR 75 - Cleared under K031613 Vectra Genisys Laser System - Cleared under K 040662 Solaris D890 - Cleared under K040729 3. PERFORMANCE STANDARDS: Klaser conforms to the applicable requirements of 21 CFR section 1010 (Performance Standards for…	Dynatronics Corp.	2004	—

Also cleared against K031612: 8 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K070400	LC Therapy, Model LCT-1000	Litecure, LLC	2007	8
K091497	K-Laser K-1200, Model 12 W	Eltech S.R.L	2009	7
K061656	Laser-D68	Laser Pain Clinics LP	2006	5
K083560	Expanded Spectrum Photo Therapy Device, Model Espt-3X	Lighthouse Technical Innovations, Inc.	2008	1
K132529	Gallieon-1 Medical Laser	Future Device and Technology, Inc.	2014	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?

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 11 ancestors has a recall.
Of its descendants, K070400 (Litecure, LLC, 2007) has gone furthest, with 8 descendants of its own.
8 other devices also cite its predicate K031612.

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

2007high 16 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILY

116in 2017

2007high 214 (2016) · low 116 (2017)2026

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

Recalls per year · ILY

1in 2025

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

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

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 device 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.

https://510kreport.com/device/K050070 · printed Nov 6, 2026

Cite this page

510(k) Report. “K050070: K-Laser, Models 3,4,4D,6D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050070

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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