510(k) · Cleared
ClearedHealthlight Microcontroller, Minipro, Proneurolight, and Pro Unit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioremedi Therapeutic Systems, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jan 21, 2011 as substantially equivalent to K931261 (Smi, 1994) after a 198-day review. Its family tree reaches back 1 generation to 1994. 2 later devices descend from it.
- Decided
- Jan 21, 2011
- Review
- 198 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K931261 (1994). 2 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK931261 Spectropad SystemSmi · 1994
- This deviceK101894 Healthlight Microcontroller, Minipro, Proneurolight, and Pro UnitBioremedi Therapeutic Systems, Inc. · 2011
- Descendant · cites it directly · 0 of its ownK153389 Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)In Light Wellness Systems, Inc. · 2016 · Recalled
- Descendant · cites it directly · 0 of its ownK142256 Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd. · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K931261 | Spectropad System | Smi | 1994 | — |
| 0 (this device) | K101894 | Healthlight Microcontroller, Minipro, Proneurolight, and Pro Unit | Bioremedi Therapeutic Systems, Inc. | 2011 | — |
| +1 | K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) | In Light Wellness Systems, Inc. | 2016 | 1 |
| +1 | K142256 | Applied BioPhotonics Phototherapy System ABPT1003 | Applied Biophotonics, Ltd. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K931261 | Spectropad SystemSummary page 2…--------------------------------- 4The BioRemedi HealthLight TM System is substantially equivalent to the -------- predicate device, the SMI SpectroPad, (K931261). Similarities Anodyne (formerly SMI) and HealthLight TM are pulsed infrared devices using a separate contr… | 1994 |
What descends from it? (2)
2 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?
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?
HealthLight MicroController, MiniPro, ProNeuroLight, and Pro Unit are intended for the following indications for use:
1. Provides heat therapy, i.e., temporarily relieves minor pain, stiffness and muscle spasm.
2. Temporarily increases local blood circulation.
It is an Rx Only medical device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K101894 · printed Nov 6, 2026
Cite this page
510(k) Report. “K101894: Healthlight Microcontroller, Minipro, Proneurolight, and Pro Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K101894
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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