510(k) · Cleared

Cleared

Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-Base, CLP-275, CLP-55.

K052647510(k) TraditionalCleared Nov 9, 200544-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

American Spine Center, Ltd. · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Nov 9, 2005 as substantially equivalent to K032231 (Medx Electronics, Inc., 2003) and 4 other predicates after a 44-day review. Its family tree reaches back 5 generations to 2000. 2 later devices descend from it.

Decided: Nov 9, 2005
Review: 44 days
Class: Class II
Product code: ILY
Recalls: None
Predicates: 5

Its longest line of descent runs back 5 generations to K001179 (2000). 29 ancestors in all, the oldest K871179 (1987). 2 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 5 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
4 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
3 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
2 generations backK040729 Solaris D890 Therapy ProbeDynatronics Corp. · 2004
1 generation backK043586 Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp. · 2005
This deviceK052647 Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300…American Spine Center, Ltd. · 2005
Descendant · cites it directly · 1 of its ownK060134 Apollo IR Heat Lamp SystemApollo Physical Therapy Products International · 2006 · Recalled
Descendant · 2 generations on · 0 of its ownK150466 ZX2 Laser SystemLzr7, Inc. · 2015

Most influential descendants

Showing 2 of 2 · See all

K060134Apollo IR Heat Lamp SystemApollo Physical Therapy Products International · 2006 · cites it directly1descendant
K150466ZX2 Laser SystemLzr7, Inc. · 2015 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−5	K001179	Super Nova, Acubeam	Light Force Therapy, Inc.	2000	—
−4	K020017	Medx 1000 Series	Medx Electronics, Inc.	2002	—
−3	K031329	Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe…	Dynatronics Corp.	2003	—
−2	K040729	Solaris D890 Therapy Probe	Dynatronics Corp.	2004	—
−1	K043586	Laser Sys*Stim 540, Model ME 540	Mettler Electronics Corp.	2005	—
0 (this device)	K052647	Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275…	American Spine Center, Ltd.	2005	—
+1	K060134	Apollo IR Heat Lamp System	Apollo Physical Therapy Products International	2006	1
+2	K150466	ZX2 Laser System	Lzr7, Inc.	2015	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1987	2	0
1988	1	0
1989	1	0
1995	4	0
1996	1	0
1997	1	0
1998	1	0
1999	1	0
2000	1	0
2001	1	0
2002	2	0
2003	4	0
2004	3	0
2005	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2006	1	0
2015	1	0

FIG. 1 — Lineage of K052647, 2000–2015Source: 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? (5)

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
*	K032231	MEDX1100 Console & Medx 100T and Duolight Laser Accessories, Medx 100 Portable Laser Summary page 1 …redicate Devices The Clini-Lase System are substantially equivalent to other infrared sources (product code ILY) currently in commercial distribution such as: K032231 MedX LCT100 & MedX LCS Portable Laser K033923 Thor DDII IR Lamp Systems K040662 Vectra Genisis Laser System K04…	Medx Electronics, Inc.	2003	—
*	K033923	TH0R Ddii IR Lamp System Summary page 1 …antially equivalent to other infrared sources (product code ILY) currently in commercial distribution such as: K032231 MedX LCT100 & MedX LCS Portable Laser K033923 Thor DDII IR Lamp Systems K040662 Vectra Genisis Laser System K043586 Laser Sys*Stim 540, Model ME 540 K050370…	Thor Intl.	2004	—
*	K040662	Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser… Summary page 1 …urces (product code ILY) currently in commercial distribution such as: K032231 MedX LCT100 & MedX LCS Portable Laser K033923 Thor DDII IR Lamp Systems K040662 Vectra Genisis Laser System K043586 Laser Sys*Stim 540, Model ME 540 K050370 Palomar LuxIR Handpiece Descripti…	Chattanooga Group	2004	—
*	K043586	Laser SysStim 540, Model ME 540 Summary page 1 …ommercial distribution such as: K032231 MedX LCT100 & MedX LCS Portable Laser K033923 Thor DDII IR Lamp Systems K040662 Vectra Genisis Laser System K043586 Laser SysStim 540, Model ME 540 K050370 Palomar LuxIR Handpiece Description of the Device The Clini-Lase System…	Mettler Electronics Corp.	2005	—
*	K050370	Palomar Luxir Handpiece Summary page 1 …MedX LCT100 & MedX LCS Portable Laser K033923 Thor DDII IR Lamp Systems K040662 Vectra Genisis Laser System K043586 Laser Sys*Stim 540, Model ME 540 K050370 Palomar LuxIR Handpiece Description of the Device The Clini-Lase System consists of a clinical and portable control ba…	Palomar Medical Technologies, Inc.	2005	—

Also cleared against K032231: 2 other devices →

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K060134	Apollo IR Heat Lamp System	Apollo Physical Therapy Products International	2006	1

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 5 companies; a new generation was cleared every 11 months on median.
1 of the 29 ancestors has a recall of any class.
Of its descendants, K060134 (Apollo Physical Therapy Products International, 2006) has gone furthest, with 1 descendant 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

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 Clini-Lase System is an infrared lamp that is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperture for the temporary relief of minor muscle and joint pain and stiffness, for the temporary relief of minor joint pain associated with arthritis, for the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Clini-Lase System may also help muscle spasms, minor sprains and strains, and minor muscular back pain.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K052647 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052647: Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155, CL-55, CLP-Base, CLP-275, CLP-55..” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052647

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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