510(k) · Cleared

Cleared

AL T Laser, Model Avi HPLL-12

K091285510(k) TraditionalCleared Jul 28, 200988-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 Jul 28, 2009 as substantially equivalent to K031612 (Avicenna Laser Technology, Inc., 2003) after an 88-day review. Its family tree reaches back 2 generations to 2000.

Decided: Jul 28, 2009
Review: 88 days
Class: Class II
Product code: ILY
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K993685 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK993685 BiopackBioscan, Inc. · 2000
1 generation backK031612 Alt Laser, Model VTR 75Avicenna Laser Technology, Inc. · 2003
This deviceK091285 AL T Laser, Model Avi HPLL-12Avicenna Laser Technology, Inc. · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K993685	Biopack	Bioscan, Inc.	2000	—
−1	K031612	Alt Laser, Model VTR 75	Avicenna Laser Technology, Inc.	2003	—
0 (this device)	K091285	AL T Laser, Model Avi HPLL-12	Avicenna Laser Technology, Inc.	2009	—

FIG. 1 — Lineage of K091285, 2000–2009Source: 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
*	K031612	Alt Laser, Model VTR 75 Summary page 1 …ALT Laser, Model AVI HPLL-12 Classification Infrared Lamp, 21 CFR 890.5500 Predicate: ALT Laser, Model VTR75, K031612 market clearance date December 11, 2003 Description The system will produce a 980nm infrared and a 650 nm…	Avicenna Laser Technology, Inc.	2003	—

Also cleared against K031612: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 9 years and passes through 2 companies; a new generation was cleared every 5.6 years on median.
None of the 2 ancestors has a recall.
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. 2009, this device’s year, is highlighted.

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 AVI HPLL-12 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/K091285 · printed Nov 4, 2026

Cite this page

510(k) Report. “K091285: AL T Laser, Model Avi HPLL-12.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091285

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