510(k) · Cleared
ClearedSpectropad System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Smi · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Mar 31, 1994 after a 384-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 9 later devices descend from it.
- Decided
- Mar 31, 1994
- Review
- 384 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 4 citing it directly.
- This deviceK931261 Spectropad SystemSmi · 1994
- Descendant · cites it directly · 3 of its ownK051681 Dermillume Red, Model HR1000Care Electronics, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK101894 Healthlight Microcontroller, Minipro, Proneurolight, and Pro UnitBioremedi Therapeutic Systems, Inc. · 2011
- Descendant · 2 generations on · 1 of its ownK081570 DPL Therapy SystemLed Technologies, LLC · 2008 · Recalled
- Descendant · cites it directly · 0 of its ownK170068 Softcure 96Wellray Medical Laser, Inc. · 2017
- Descendant · 2 generations on · 0 of its ownK153389 Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)In Light Wellness Systems, Inc. · 2016 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K051681Dermillume Red, Model HR1000Care Electronics, Inc. · 2005 · cites it directly3descendants
- K101894Healthlight Microcontroller, Minipro, Proneurolight, and Pro UnitBioremedi Therapeutic Systems, Inc. · 2011 · cites it directly2descendants
- K081570DPL Therapy SystemLed Technologies, LLC · 2008 · 2 generations on1descendant
- K170068Softcure 96Wellray Medical Laser, Inc. · 2017 · cites it directly0descendants
- K153389Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)In Light Wellness Systems, Inc. · 2016 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K931261 | Spectropad System | Smi | 1994 | — |
| +1 | K051681 | Dermillume Red, Model HR1000 | Care Electronics, Inc. | 2005 | — |
| +1 | K101894 | Healthlight Microcontroller, Minipro, Proneurolight, and Pro Unit | Bioremedi Therapeutic Systems, Inc. | 2011 | — |
| +2 | K081570 | DPL Therapy System | Led Technologies, LLC | 2008 | 1 |
| +1 | K170068 | Softcure 96 | Wellray Medical Laser, Inc. | 2017 | — |
| +2 | K153389 | Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) | In Light Wellness Systems, Inc. | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (9)
4 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?
- Of its descendants, K051681 (Care Electronics, Inc., 2005) has gone furthest, with 3 descendants of its own.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K931261 · printed Nov 6, 2026
Cite this page
510(k) Report. “K931261: Spectropad System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K931261
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026