510(k) · Cleared
ClearedLumanosity Celebrity, Model 204
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lumanosity, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Oct 4, 2010 as substantially equivalent to K080102 (Escada International, Inc., 2008) after a 252-day review. Its family tree reaches back 1 generation to 2008. 2 later devices descend from it.
- Decided
- Oct 4, 2010
- Review
- 252 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K080102 (2008). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK080102 TQ Solo and Solo Pro and LS50 Accessory and MR4 Multi Radiance…Escada International, Inc. · 2008
- This deviceK100213 Lumanosity Celebrity, Model 204Lumanosity, Inc. · 2010
- Descendant · cites it directly · 1 of its ownK112494 Varaya AR , Varaya SportVaraya Photoceuticals, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK150716 Varaya SportVaraya Photoceuticals, LLC · 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 | K080102 | TQ Solo and Solo Pro and LS50 Accessory and MR4 Multi Radiance Therapy System | Escada International, Inc. | 2008 | — |
| 0 (this device) | K100213 | Lumanosity Celebrity, Model 204 | Lumanosity, Inc. | 2010 | — |
| +1 | K112494 | Varaya AR , Varaya Sport | Varaya Photoceuticals, LLC | 2012 | — |
| +2 | K150716 | Varaya Sport | Varaya Photoceuticals, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2015 | 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 |
|---|---|---|---|
| * | K080102 | TQ Solo and Solo Pro and LS50 Accessory and MR4 Multi Radiance Therapy SystemSummary page 4…is 501 k is to register a new product for sale in the market which is a finished component Predicate Devices Device 1 Name: TERRAQUANT SOLO PRO 510(k) Number: K080102 ControlIs IEC 62471 Photobiological Safety of Lamps and Lamps Systems Part 11 Guidance on Mfg Requirements relating to non- las… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112494 | Varaya AR , Varaya Sport | 2012 | 1 |
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?
- Its one ancestor has no recall.
- Of its descendants, K112494 (Varaya Photoceuticals, LLC, 2012) has gone furthest, with 1 descendant 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. 2010, 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?
Temporary relief of minor muscle and joint pain, arthritis and muscle spasm,
relieving stiffness, promoting relaxation of muscle tissue, and to temporarily
increase local blood circulation where heat is indicated
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100213 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100213: Lumanosity Celebrity, Model 204.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100213
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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