510(k) · Cleared
ClearedHilthera 4.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Jeisys Medical, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jan 7, 2015 as substantially equivalent to K051537 (Cynosure, Inc., 2005) after a 181-day review. Its family tree reaches back 1 generation to 2005. 20 later devices descend from it.
- Decided
- Jan 7, 2015
- Review
- 181 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K051537 (2005). 20 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK051537 Hilt Family Laser: Hilt I, Hilt II, Hilt IiiCynosure, Inc. · 2005
- This deviceK141861 Hilthera 4.0Jeisys Medical, Inc. · 2015
- Descendant · cites it directly · 19 of its ownK191554 LightWalker Laser System FamilyFotona D.O.O. · 2019
- Descendant · 2 generations on · 11 of its ownK193656 SkyPulseFotona D.O.O. · 2020
- Descendant · 2 generations on · 8 of its ownK193661 LightWalker Laser System FamilyFotona D.O.O. · 2020
- Descendant · 3 generations on · 7 of its ownK202985 LightWalker Laser System FamilyFotona D.O.O. · 2021
- Descendant · 3 generations on · 3 of its ownK202991 Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K191554LightWalker Laser System FamilyFotona D.O.O. · 2019 · cites it directly19descendants
- K193656SkyPulseFotona D.O.O. · 2020 · 2 generations on11descendants
- K193661LightWalker Laser System FamilyFotona D.O.O. · 2020 · 2 generations on8descendants
- K202985LightWalker Laser System FamilyFotona D.O.O. · 2021 · 3 generations on7descendants
- K202991Fotona XPulse Pro Laser PlatformFotona D.O.O. · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K051537 | Hilt Family Laser: Hilt I, Hilt II, Hilt Iii | Cynosure, Inc. | 2005 | — |
| 0 (this device) | K141861 | Hilthera 4.0 | Jeisys Medical, Inc. | 2015 | — |
| +1 | K191554 | LightWalker Laser System Family | Fotona D.O.O. | 2019 | — |
| +2 | K193656 | SkyPulse | Fotona D.O.O. | 2020 | — |
| +2 | K193661 | LightWalker Laser System Family | Fotona D.O.O. | 2020 | — |
| +3 | K202985 | LightWalker Laser System Family | Fotona D.O.O. | 2021 | — |
| +3 | K202991 | Fotona XPulse Pro Laser Platform | Fotona D.O.O. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
| 2025 | 4 | 0 |
| 2026 | 3 | 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 |
|---|---|---|---|
| * | K051537 | Hilt Family Laser: Hilt I, Hilt II, Hilt IiiSummary page 4…ILY Device Class: Class II Classification Panel: Infrared Lamp 5. Predicate Devices El En SpA – El En HILT Family Laser, K051537 6. Device Description - Device Specification A complete device specification is included in attachment 11 and in the Operator's… | 2005 |
What descends from it? (20)
See all 201 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K191554 | LightWalker Laser System Family | 2019 | 19 |
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. 2015, 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 provide topical heating for the purpose of elevating tissue temperature for temporary relief of muscle and joint pain
and stiffness, arthritis pain, or muscle spasm, the temporary increase in local blood circulation and/or promoting
relaxation of muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141861 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141861: Hilthera 4.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141861
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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