510(k) Report

510(k) · Cleared

Cleared

Lumina 1600, 3300 and 6600 Systems

K052814510(k) TraditionalCleared Nov 30, 200557-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

Usa Laser Biotech, Inc. · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Nov 30, 2005 as substantially equivalent to K031612 (Avicenna Laser Technology, Inc., 2003) and 2 other predicates after a 57-day review. Its family tree reaches back 2 generations to 2000. 8 later devices descend from it.

Decided
Nov 30, 2005
Review
57 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K001179 (2000). 4 ancestors in all, the oldest K993685 (2000). 8 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2000: 1 other ancestor2012: 1 descendant cleared2011: 1 descendant cleared2009: 1 descendant cleared2016: 2 descendants cleared2015: 2 descendants cleared2017: 1 descendant clearedK001179 · Super Nova, Acubeam · Light Force Therapy, Inc. · 2000K023621 · Bioflex Professional Therapy System · Meditech International, Inc. · 2003200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 5 descendants K023621 · Bioflex Professional Therapy System · Meditech International, Inc. · 2003K001179 · Super Nova, Acubeam · Light Force Therapy, Inc. · 20000
  1. Root · 2 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
  2. 1 generation backK023621 Bioflex Professional Therapy SystemMeditech International, Inc. · 2003
  3. This deviceK052814 Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc. · 2005
  4. 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
  5. Descendant · cites it directly · 5 of its ownK101893 Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp…Usa Laser Biotech, Inc. · 2011
  6. Descendant · 2 generations on · 0 of its ownK171087 AXON IR Heat LampCrystal Medtech, LLC · 2017
  7. Descendant · 2 generations on · 0 of its ownK161198 Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
  8. Descendant · 2 generations on · 0 of its ownK160947 LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR…Usa Laser Biotech, Inc. · 2016

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2009: 12011: 12012: 12015: 22016: 22017: 1
2009high 2 (2015) · low 0 (2010)2026

Most influential descendants

Showing 5 of 8 · See all
  • K091726Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980Usa Laser Biotech, Inc. · 2009 · cites it directly6descendants
  • K101893Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus…Usa Laser Biotech, Inc. · 2011 · cites it directly5descendants
  • K171087AXON IR Heat LampCrystal Medtech, LLC · 2017 · 2 generations on0descendants
  • K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016 · 2 generations on0descendants
  • K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K001179Super Nova, AcubeamLight Force Therapy, Inc.2000—
−1K023621Bioflex Professional Therapy SystemMeditech International, Inc.2003—
0 (this device)K052814Lumina 1600, 3300 and 6600 SystemsUsa Laser Biotech, Inc.2005—
+1K091726Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980Usa Laser Biotech, Inc.2009—
+1K101893Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System…Usa Laser Biotech, Inc.2011—
+2K171087AXON IR Heat LampCrystal Medtech, LLC2017—
+2K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc.2016—
+2K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp…Usa Laser Biotech, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200010
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
201110
201210
201520
201620
201710
FIG. 1 — Lineage of K052814, 2000–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

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.

TypeNumberDeviceApplicantDecidedRecalls
*K031612Alt Laser, Model VTR 75
Summary page 1
…that are currently in commercial distribution. These predicate devices include, but are not limited to, the Avicenna Laser Therapy, Inc. ALT Laser Model VTR 75 (K031612), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), and Meditech International, Inc. BioFlex…
Avicenna Laser Technology, Inc.2003—
*K001179Super Nova, Acubeam
Summary page 1
…e, but are not limited to, the Avicenna Laser Therapy, Inc. ALT Laser Model VTR 75 (K031612), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), and Meditech International, Inc. BioFlex Professional Therapy System (K023621). V. Description of the Device…
Light Force Therapy, Inc.2000—
*K023621Bioflex Professional Therapy System
Summary page 1
…75 (K031612), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), and Meditech International, Inc. BioFlex Professional Therapy System (K023621). V. Description of the Device The LUMINA 1600, 3300 and 6600 Systems are easy to use, non-invasive therapeutic…
Meditech International, Inc.2003—

Also cleared against K031612: 8 other devices →

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K091726Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980Usa Laser Biotech, Inc.20096
K101893Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus…Usa Laser Biotech, Inc.20115
K112016L-Ser KO LampYa-Man, Ltd.20120

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 3 companies; a new generation was cleared every 2.6 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K091726 (Usa Laser Biotech, Inc., 2009) has gone furthest, with 6 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

2007: 102008: 162009: 132010: 82011: 92012: 112013: 92014: 112015: 112016: 82017: 52020: 12022: 22023: 12024: 12025: 12026 (partial year): 1
2007high 16 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILY

116in 2017

2007: 128 days median2008: 165 days median2009: 189 days median2010: 185 days median2011: 198 days median2012: 130 days median2013: 211 days median2014: 153 days median2015: 146 days median2016: 214 days median2017: 116 days median
2007high 214 (2016) · low 116 (2017)2026

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

Recalls per year · ILY

1in 2025

2010: 12012: 32022: 42023: 12025: 12026 (partial year): 1
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

2007: 242008: 202009: 92010: 72011: 102012: 72013: 82015: 22016: 22017: 122018: 12019: 72020: 52021: 52022: 22023: 152024: 192025: 17
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200710128024
200816165020
20091318909
2010818517
20119198010
20121113037
2013921108
20141115300
20151114602
2016821402
20175116012
20180—01
20190—07
20201—05
20210—05
20222—42
20231—115
20241—019
20251—117
20261—1—

What is it indicated for?

The LUMINA Systems, as listed above, are intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.

Indications for use as stated in the FDA summary.

Also cleared against K031612

8 other devices cite the same predicate.

  • K132529Gallieon-1 Medical LaserFuture Device and Technology, Inc. · 2014
  • K112016L-Ser KO LampYa-Man, Ltd. · 2012
  • K091726Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980Usa Laser Biotech, Inc. · 2009
  • K091285AL T Laser, Model Avi HPLL-12Avicenna Laser Technology, Inc. · 2009
  • K083560Expanded Spectrum Photo Therapy Device, Model Espt-3XLighthouse Technical Innovations, Inc. · 2008
  • K070400LC Therapy, Model LCT-1000Litecure, LLC · 2007

More from Usa Laser Biotech, Inc.

6 FDA decisions under this applicant name. See the company

  • K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
  • K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX CPS 4 IR Lamp System…Usa Laser Biotech, Inc. · 2016
  • K101893Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus Biowave 30W Pro IR Lamp…Usa Laser Biotech, Inc. · 2011
  • K091726Nexus Xpulse 805 IR Lamp System, Nexus Xpulse 980 IR Lamp System, Model 805, 980Usa Laser Biotech, Inc. · 2009
  • K042256IR Heat Lamp Systems: Icl 15 HFPL System, Icl 60 Plus HFPL System (Models 40, 100 and 250), Icl 100 Activo…Usa Laser Biotech, Inc. · 2004

Recent decisions in ILY

The ILY category page

  • K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight…Wuhan PHOMED Technology Company, Ltd. · 2026
  • K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company, Ltd. · 2025
  • K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc. · 2024
  • K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V. · 2023
  • K221189Oliz LTB-1000ALtbio Co., Ltd. · 2022

https://510kreport.com/device/K052814 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052814: Lumina 1600, 3300 and 6600 Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052814

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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