510(k) · Cleared
ClearedLumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Usa Laser Biotech, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jul 26, 2016 as substantially equivalent to K132016 (Texas Applied Biomedical Services, Inc., 2014) and 3 other predicates after an 89-day review. Its family tree reaches back 17 generations to 1995.
- Decided
- Jul 26, 2016
- Review
- 89 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 17 generations to K943450 (1995). 125 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK083629 SmoothshapesEleme Medical, Inc. · 2009
- 2 generations backK100230 Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc. · 2010
- 1 generation backK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
- This deviceK161198 Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 5 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 4 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 3 generations backK083629 SmoothshapesEleme Medical, Inc. · 2009
- 2 generations backK100230 Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc. · 2010
- 1 generation backK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
- This deviceK161198 Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −5 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −4 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| −3 | K083629 | Smoothshapes | Eleme Medical, Inc. | 2009 | — |
| −2 | K100230 | Smoothshapes System, 11318-120V, 11319-230V | Eleme Medical, Inc. | 2010 | — |
| −1 | K123971 | Cynosure 1064NM Diode Laser | Cynosure, Inc. | 2013 | — |
| 0 (this device) | K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 7 | 0 |
| 1996 | 10 | 0 |
| 1997 | 7 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 10 | 0 |
| 2001 | 3 | 0 |
| 2002 | 11 | 0 |
| 2003 | 10 | 0 |
| 2004 | 7 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
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
What was it cleared against? (4)
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 | Decided |
|---|---|---|---|
| * | K132016 | Lumix 3 Plus and Lumix 3 Ultra SystemSummary page 5…rcial distribution. These predicate devices include, but are not limited to: 1. USA Laser Biotech Inc. LUMIX 3 Series Infrared Heat Lamp Therapy Systems (K132016), 2. USA Laser Biotech Inc. NEXUS Series IR Heat Lamp Systems (K101893), 3. CYNOSURE 1064nm Diode Lase… | 2014 |
| * | K101893 | Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus…Summary page 5…aser Biotech Inc. LUMIX 3 Series Infrared Heat Lamp Therapy Systems (K132016), 2. USA Laser Biotech Inc. NEXUS Series IR Heat Lamp Systems (K101893), 3. CYNOSURE 1064nm Diode Laser (K123971), and 4. ELTECH s.r.l. K-Laser Cube 1, K-Laser Cube 2, K-Laser Cube 3, K-La… | 2011 |
| * | K123971 | Cynosure 1064NM Diode LaserSummary page 5…amp Therapy Systems (K132016), 2. USA Laser Biotech Inc. NEXUS Series IR Heat Lamp Systems (K101893), 3. CYNOSURE 1064nm Diode Laser (K123971), and 4. ELTECH s.r.l. K-Laser Cube 1, K-Laser Cube 2, K-Laser Cube 3, K-Laser Cube 4 (K120604). V.… | 2013 |
| * | K120604 | K-LaserSummary page 5…s (K101893), 3. CYNOSURE 1064nm Diode Laser (K123971), and 4. ELTECH s.r.l. K-Laser Cube 1, K-Laser Cube 2, K-Laser Cube 3, K-Laser Cube 4 (K120604). V. Summary of the Technical Characteristics of the LUMIX ULTRA System as Related to the Referenced Pre… | 2012 |
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 21 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 5 of the 125 ancestors have a recall of any class.
- 2 other devices also cite its predicate K132016.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 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 LUMIX ULTRA IR Lamp Systems are intended to emit energy in the visible and 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.
https://510kreport.com/device/K161198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161198: Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161198
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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