510(k) · Cleared
ClearedVevazz LED Heat Lamp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vevazz, LLC · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jan 5, 2017 as substantially equivalent to K101716 (H.V.R., Inc., 2011) and 2 other predicates after a 97-day review. Its family tree reaches back 6 generations to 1998.
- Decided
- Jan 5, 2017
- Review
- 97 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K974468 (1998). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK974468 Photonic StimulatorBales Scientific, Inc. · 1998
- 5 generations backK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
- 4 generations backK043055 Terraquant MQ2000 Laser Therapy DeviceEscada International, Inc. · 2005
- 3 generations backK061614 Terraquant MQ2000 V. 5 and Handyrx MQ2007 LasersEscada International, Inc. · 2006
- 2 generations backK083580 Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC · 2009
- 1 generation backK120582 HeatluxHome Skinovations, Ltd. · 2012
- This deviceK162763 Vevazz LED Heat LampVevazz, LLC · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K974468 | Photonic Stimulator | Bales Scientific, Inc. | 1998 | — |
| −5 | K032229 | Quantum Warp 10 Light Delivery System | Quantum Devices, Inc. | 2003 | — |
| −4 | K043055 | Terraquant MQ2000 Laser Therapy Device | Escada International, Inc. | 2005 | — |
| −3 | K061614 | Terraquant MQ2000 V. 5 and Handyrx MQ2007 Lasers | Escada International, Inc. | 2006 | — |
| −2 | K083580 | Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301 | Led Intellectual Properties, LLC | 2009 | — |
| −1 | K120582 | Heatlux | Home Skinovations, Ltd. | 2012 | — |
| 0 (this device) | K162763 | Vevazz LED Heat Lamp | Vevazz, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 2 | 0 |
| 2002 | 2 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 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? (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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K101716 | HVR Pain Relief DeviceSummary page 5…th a wavelength of 650 nm; +/- 25 nm uniformly over the treatment area without producing hot spots. 6. Predicate Devices HVR Infrared Lamp by HVR, LLC - K101716 Tanda Restore by Pharos Life Corporation - K090008 HEATLUX by Home Skinnovations, LTD. - K120582 7. Tech… | 2011 |
| * | K090008 | Tanda Restore, Model PtscsSummary page 5…tment area without producing hot spots. 6. Predicate Devices HVR Infrared Lamp by HVR, LLC - K101716 Tanda Restore by Pharos Life Corporation - K090008 HEATLUX by Home Skinnovations, LTD. - K120582 7. Technical and Performance Substantial Equivalency The submissio… | 2009 |
| * | K120582 | HeatluxSummary page 5…cate Devices HVR Infrared Lamp by HVR, LLC - K101716 Tanda Restore by Pharos Life Corporation - K090008 HEATLUX by Home Skinnovations, LTD. - K120582 7. Technical and Performance Substantial Equivalency The submission and predicate devices are fully compliant with USFDA… | 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 19 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- None of the 15 ancestors has a recall.
- 2 other devices also cite its predicate K101716.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 Vevazz is a device that emits energy in the infrared spectrum and is to be used to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, stiffness or muscle spasms; the temporary increasing of local blood circulation and/or the temporary relaxation of muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162763 · printed Nov 5, 2026
Cite this page
510(k) Report. “K162763: Vevazz LED Heat Lamp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K162763
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