510(k) · Cleared
ClearedHilt Family Laser: Hilt I, Hilt II, Hilt Iii
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Sep 26, 2005 after a 108-day review. The FDA summary names its predicate without a number. 47 later devices descend from it.
- Decided
- Sep 26, 2005
- Review
- 108 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 0
47 later devices descend from it, 2 citing it directly.
- This deviceK051537 Hilt Family Laser: Hilt I, Hilt II, Hilt IiiCynosure, Inc. · 2005
- Descendant · cites it directly · 25 of its ownK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
- Descendant · 2 generations on · 21 of its ownK150724 SculpSureCynosure, Inc. · 2015
- Descendant · 2 generations on · 21 of its ownK150230 SculpSureCynosure, Inc. · 2015
- Descendant · 3 generations on · 20 of its ownK160470 SculpSureCynosure, Inc. · 2016
- Descendant · cites it directly · 20 of its ownK141861 Hilthera 4.0Jeisys Medical, Inc. · 2015
Showing 5 of 47 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 47 · See all- K123971Cynosure 1064NM Diode LaserCynosure, Inc. · 2013 · cites it directly25descendants
- K150724SculpSureCynosure, Inc. · 2015 · 2 generations on21descendants
- K150230SculpSureCynosure, Inc. · 2015 · 2 generations on21descendants
- K160470SculpSureCynosure, Inc. · 2016 · 3 generations on20descendants
- K141861Hilthera 4.0Jeisys Medical, Inc. · 2015 · cites it directly20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K051537 | Hilt Family Laser: Hilt I, Hilt II, Hilt Iii | Cynosure, Inc. | 2005 | — |
| +1 | K123971 | Cynosure 1064NM Diode Laser | Cynosure, Inc. | 2013 | — |
| +2 | K150724 | SculpSure | Cynosure, Inc. | 2015 | — |
| +2 | K150230 | SculpSure | Cynosure, Inc. | 2015 | — |
| +3 | K160470 | SculpSure | Cynosure, Inc. | 2016 | — |
| +1 | K141861 | Hilthera 4.0 | Jeisys Medical, Inc. | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 4 | 0 |
| 2020 | 4 | 0 |
| 2021 | 4 | 0 |
| 2022 | 7 | 0 |
| 2023 | 5 | 0 |
| 2024 | 6 | 0 |
| 2025 | 5 | 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 |
|---|---|---|---|
| * | — | MLT-1000 IR Laser System Named without a submission number |
What descends from it? (47)
See all 472 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, K123971 (Cynosure, Inc., 2013) has gone furthest, with 25 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 | — |
What is it indicated for?
The HILT Family Laser is intended to provide topical heating for the purpose of elevating tissue temperature for the 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/K051537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051537: Hilt Family Laser: Hilt I, Hilt II, Hilt Iii.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051537
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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