510(k) · Cleared
Recalled · Class III · 2019Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
In Light Wellness Systems, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Mar 30, 2016 as substantially equivalent to K101894 (Bioremedi Therapeutic Systems, Inc., 2011) after a 128-day review. Its family tree reaches back 2 generations to 1994. It has been recalled once.
- Decided
- Mar 30, 2016
- Review
- 128 days
- Class
- Class II
- Product code
- ILY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931261 (1994). No later device cites it as a predicate yet.
- Root · 2 generations backK931261 Spectropad SystemSmi · 1994
- 1 generation backK101894 Healthlight Microcontroller, Minipro, Proneurolight, and Pro UnitBioremedi Therapeutic Systems, Inc. · 2011
- This deviceK153389 Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)In Light Wellness Systems, Inc. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931261 | Spectropad System | Smi | 1994 | — |
| −1 | K101894 | Healthlight Microcontroller, Minipro, Proneurolight, and Pro Unit | Bioremedi Therapeutic Systems, Inc. | 2011 | — |
| 0 (this device) | K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) | In Light Wellness Systems, Inc. | 2016 | — |
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 |
|---|---|---|---|
| * | K101894 | Healthlight Microcontroller, Minipro, Proneurolight, and Pro UnitSummary page 4…vice is Substantially Equivalent Company Device K Number Bioremedi HealthLightTM System K101894 Therapeutic Systems, Inc. Device Description ElysiomTM Polychromatic LED Light Therapy (PLLT) System is a pulsed light emitti… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2019 | Class III | Z-1943-2021 | Component change control | LED pads with cord connectors that have v-shaped notches may not have been assembled properly. This issue could lead to a power interruption, causing the controller and power supply to shut down. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 16.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K101894.
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?
To: 1) temporarily relieve minor pain, stiffness and muscle spasms; and
2) temporarily increase the local blood circulation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K153389 · printed Nov 4, 2026
Cite this page
510(k) Report. “K153389: Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K153389
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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