510(k) · Cleared

Cleared

Alt Laser, Model VTR 75

K031612510(k) TraditionalCleared Dec 11, 2003203-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

Avicenna Laser Technology, Inc. · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Dec 11, 2003 as substantially equivalent to K993685 (Bioscan, Inc., 2000) after a 203-day review. Its family tree reaches back 1 generation to 2000. 22 later devices descend from it.

Decided: Dec 11, 2003
Review: 203 days
Class: Class II
Product code: ILY
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K993685 (2000). 22 later devices descend from it, 9 citing it directly.

By dateBy generation

Root · 1 generation backK993685 BiopackBioscan, Inc. · 2000
This deviceK031612 Alt Laser, Model VTR 75Avicenna Laser Technology, Inc. · 2003
Descendant · cites it directly · 12 of its ownK050070 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 · 8 of its ownK052814 Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc. · 2005
Descendant · 2 generations on · 7 of its ownK091497 K-Laser K-1200, Model 12 WEltech S.R.L · 2009
Descendant · cites it directly · 6 of its ownK091726 Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System…Usa Laser Biotech, Inc. · 2009

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2005high 3 (2005) · low 0 (2010)2026

Most influential descendants

Showing 5 of 22 · See all

K050070K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005 · cites it directly12descendants
K070400LC Therapy, Model LCT-1000Litecure, LLC · 2007 · cites it directly8descendants
K052814Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc. · 2005 · cites it directly8descendants
K091497K-Laser K-1200, Model 12 WEltech S.R.L · 2009 · 2 generations on7descendants
K091726Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980Usa Laser Biotech, Inc. · 2009 · cites it directly6descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K993685	Biopack	Bioscan, Inc.	2000	—
0 (this device)	K031612	Alt Laser, Model VTR 75	Avicenna Laser Technology, Inc.	2003	—
+1	K050070	K-Laser, Models 3,4,4D,6D	Eltech S.R.L	2005	—
+1	K070400	LC Therapy, Model LCT-1000	Litecure, LLC	2007	—
+1	K052814	Lumina 1600, 3300 and 6600 Systems	Usa Laser Biotech, Inc.	2005	—
+2	K091497	K-Laser K-1200, Model 12 W	Eltech S.R.L	2009	—
+1	K091726	Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980	Usa Laser Biotech, Inc.	2009	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	3	0
2006	2	0
2007	1	0
2008	2	0
2009	3	0
2011	2	0
2012	2	0
2014	2	0
2015	2	0
2016	2	0
2017	1	0

FIG. 1 — Lineage of K031612, 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? (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
*	K993685	Biopack Summary page 1 …63 Date August 22, 2003 Name A~L-T Laser, Model VTR75 Classification Infrared Lamp, 21 CFR 890.5500 Predicate: BioScan, Inc., BioPack, K993685 market clearance date July 18, 2000 Description The system will produce a 980mn infrared and a 660 nm red visible laser…	Bioscan, Inc.	2000	—

What descends from it? (22)

See all 22

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

Number	Device	Applicant	Decided	Descendants
K050070	K-Laser, Models 3,4,4D,6D	Eltech S.R.L	2005	12
K070400	LC Therapy, Model LCT-1000	Litecure, LLC	2007	8
K052814	Lumina 1600, 3300 and 6600 Systems	Usa Laser Biotech, Inc.	2005	8
K091726	Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980	Usa Laser Biotech, Inc.	2009	6
K041885	Bioflex LD-175 and LD-1200 Treatment Heads	Meditech International, Inc.	2005	2
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
K112016	L-Ser KO Lamp	Ya-Man, Ltd.	2012	0
K091285	AL T Laser, Model Avi HPLL-12	Avicenna Laser Technology, Inc.	2009	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, K050070 (Eltech S.R.L, 2005) has gone furthest, with 12 descendants of its own.

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?

ALT Laser, Model VTR75 is intended to emit energy in the infrared spectrum to provide topical heating for use when heat is indicated in the temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis, and promoting relaxation of the muscle tissue.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031612 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031612: Alt Laser, Model VTR 75.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031612

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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