510(k) · Cleared

Cleared

Medx 1000 Series

K020017510(k) TraditionalCleared Jul 12, 2002190-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

Medx Electronics, Inc. · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Jul 12, 2002 as substantially equivalent to K001179 (Light Force Therapy, Inc., 2000) after a 190-day review. Its family tree reaches back 1 generation to 2000. 187 later devices descend from it.

Decided: Jul 12, 2002
Review: 190 days
Class: Class II
Product code: ILY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K001179 (2000). 187 later devices descend from it, 8 citing it directly.

By dateBy generation

Root · 1 generation backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
This deviceK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
Descendant · cites it directly · 74 of its ownK032231 MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx…Medx Electronics, Inc. · 2003
Descendant · cites it directly · 73 of its ownK032816 Quantum Light Therapy SystemStargate International, Inc. · 2004
Descendant · 2 generations on · 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 ownK091496 Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010
Descendant · 3 generations on · 58 of its ownK083595 EzlaseBiolase Technology, Inc. · 2009

Showing 5 of 187 descendants. See all descendants

Descendants cleared per year

2003high 18 (2025) · low 2 (2007)2026

Most influential descendants

Showing 5 of 187 · See all

K032231MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable LaserMedx Electronics, Inc. · 2003 · cites it directly74descendants
K032816Quantum Light Therapy SystemStargate International, Inc. · 2004 · cites it directly73descendants
K082707Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable LaserMedx Electronics, Inc. · 2008 · 2 generations on59descendants
K091496Mep-90 Hair Growth Stimulation SystemMidwest Rf, LLC · 2010 · 2 generations on58descendants
K083595EzlaseBiolase Technology, Inc. · 2009 · 3 generations on58descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K001179	Super Nova, Acubeam	Light Force Therapy, Inc.	2000	—
0 (this device)	K020017	Medx 1000 Series	Medx Electronics, Inc.	2002	—
+1	K032231	MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable…	Medx Electronics, Inc.	2003	—
+1	K032816	Quantum Light Therapy System	Stargate International, Inc.	2004	—
+2	K082707	Medx LPT 200 Tethered Laser & Medx LPS 200 (Oralase) Portable Laser	Medx Electronics, Inc.	2008	—
+2	K091496	Mep-90 Hair Growth Stimulation System	Midwest Rf, LLC	2010	—
+3	K083595	Ezlase	Biolase Technology, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	3	0
2004	6	0
2005	9	0
2006	4	0
2007	2	0
2008	8	0
2009	4	0
2010	3	0
2011	2	0
2012	8	0
2013	4	0
2014	3	0
2015	10	0
2016	12	0
2017	6	0
2018	12	0
2019	9	0
2020	9	0
2021	6	0
2022	9	0
2023	12	0
2024	17	0
2025	18	0
2026	11	0

FIG. 1 — Lineage of K020017, 2000–2026Source: 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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K001179	Super Nova, Acubeam	Light Force Therapy, Inc.	2000	—

Also cleared against K001179: 12 other devices →

What descends from it? (187)

See all 187

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

Number	Device	Applicant	Decided	Descendants
K032231	MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable Laser	Medx Electronics, Inc.	2003	74
K032816	Quantum Light Therapy System	Stargate International, Inc.	2004	73
K031329	Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe (Optional…	Dynatronics Corp.	2003	37
K032787	Neurolase, Models 150V, 150C, 1064	Spectrum Laser & Technologies	2003	15
K090008	Tanda Restore, Model Ptscs	Pharos Life Corporation	2009	6
K050022	Medx Home	Medx Electronics, Inc.	2005	0
K030275	MB System, Bioenergy Light Therapy	Amest Corp.	2004	0
K033183	Reclear Phototherapy System, Model FGCM0012	Curelight, Ltd.	2004	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?

Its one ancestor has no recall.
Of its descendants, K032231 (Medx Electronics, Inc., 2003) has gone furthest, with 74 descendants of its own.
12 other devices also cite its predicate K001179.

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 MedX 1000 Series is an infrared lamp, as per 21 CFR 890.5500. It emits energy to provide 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, and minor pain and stiffness associated with arthritis. For use when heat is indicated for the treatment of the fore mentioned conditions.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K020017 · printed Nov 6, 2026

Cite this page

510(k) Report. “K020017: Medx 1000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020017

Report an extraction error

Are you the manufacturer?

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