510(k) · Cleared
ClearedHVR Pain Relief Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H.V.R., Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jan 11, 2011 as substantially equivalent to K032229 (Quantum Devices, Inc., 2003) after a 207-day review. Its family tree reaches back 2 generations to 1998. 5 later devices descend from it.
- Decided
- Jan 11, 2011
- Review
- 207 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K974468 (1998). 4 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK974468 Photonic StimulatorBales Scientific, Inc. · 1998
- 1 generation backK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
- This deviceK101716 HVR Pain Relief DeviceH.V.R., Inc. · 2011
- Descendant · cites it directly · 3 of its ownK120582 HeatluxHome Skinovations, Ltd. · 2012
- Descendant · 2 generations on · 1 of its ownK150175 HeatLux Pro IHome Skinovations, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK251781 Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK162763 Vevazz LED Heat LampVevazz, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK152087 HeatLux Pro IIHome Skinovations, Ltd. · 2016
Most influential descendants
Showing 5 of 5 · See all- K120582HeatluxHome Skinovations, Ltd. · 2012 · cites it directly3descendants
- K150175HeatLux Pro IHome Skinovations, Ltd. · 2015 · 2 generations on1descendant
- K251781Kala Mini 2.0 (Kala-04)Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2025 · cites it directly0descendants
- K162763Vevazz LED Heat LampVevazz, LLC · 2017 · cites it directly0descendants
- K152087HeatLux Pro IIHome Skinovations, Ltd. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K974468 | Photonic Stimulator | Bales Scientific, Inc. | 1998 | — |
| −1 | K032229 | Quantum Warp 10 Light Delivery System | Quantum Devices, Inc. | 2003 | — |
| 0 (this device) | K101716 | HVR Pain Relief Device | H.V.R., Inc. | 2011 | — |
| +1 | K120582 | Heatlux | Home Skinovations, Ltd. | 2012 | — |
| +2 | K150175 | HeatLux Pro I | Home Skinovations, Ltd. | 2015 | — |
| +1 | K251781 | Kala Mini 2.0 (Kala-04) | Shenzhen Kaiyan Medical Equipment Co., Ltd. | 2025 | — |
| +1 | K162763 | Vevazz LED Heat Lamp | Vevazz, LLC | 2017 | — |
| +3 | K152087 | HeatLux Pro II | Home Skinovations, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2025 | 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? (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 | Decided |
|---|---|---|---|
| * | K032229 | Quantum Warp 10 Light Delivery System Our reading of the summary gave K032129, FDA’s number for Radius 018 Cougar Wire (Radius Medical Technologies, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Quantum WARP 10”. | 2003 |
What descends from it? (5)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 13 years and passes through 3 companies; a new generation was cleared every 7.3 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K120582 (Home Skinovations, Ltd., 2012) has gone furthest, with 3 descendants of its own.
- 14 other devices also cite its predicate K032229.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 HVR device is an over-the-counter handheld device used for the treatment of chronic pain by emitting energy in the near-infrared spectrum for the temporary relief of minor aches and pains in muscles and joints, arthritis and muscle spasms, relieving stiffness, promoting relaxation of muscle tissue and to temporarily increase local blood circulation where applied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101716 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101716: HVR Pain Relief Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101716
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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