510(k) · Cleared
ClearedCynosure 1064NM Diode Laser
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 May 2, 2013 as substantially equivalent to K083595 (Biolase Technology, Inc., 2009) and 2 other predicates after a 127-day review. Its family tree reaches back 16 generations to 1995. 25 later devices descend from it.
- Decided
- May 2, 2013
- Review
- 127 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 16 generations to K943450 (1995). 101 ancestors in all, the oldest K800617 (1980). 25 later devices descend from it, 4 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 2 generations backK083629 SmoothshapesEleme Medical, Inc. · 2009
- 1 generation backK100230 Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc. · 2010
- This deviceK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
- Descendant · cites it directly · 21 of its ownK150724 SculpSureCynosure, Inc. · 2015
- Descendant · cites it directly · 21 of its ownK150230 SculpSureCynosure, Inc. · 2015
- Descendant · 2 generations on · 20 of its ownK160470 SculpSureCynosure, Inc. · 2016
- Descendant · 3 generations on · 10 of its ownK171111 SculpsureCynosure, Inc. · 2017
- Descendant · 4 generations on · 8 of its ownK171992 SculpSureCynosure, Inc. · 2017
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK050397 Velasmooth, ShaperSyneron Medical, Ltd. · 2005
- 4 generations backK053611 SmoothshapesBicellulase, Inc. · 2006
- 3 generations backK061603 SmoothshapesBiocellulase, Inc. · 2006
- 2 generations backK083629 SmoothshapesEleme Medical, Inc. · 2009
- 1 generation backK100230 Smoothshapes System, 11318-120V, 11319-230VEleme Medical, Inc. · 2010
- This deviceK123971 Cynosure 1064NM Diode LaserCynosure, Inc. · 2013
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K150724SculpSureCynosure, Inc. · 2015 · cites it directly21descendants
- K150230SculpSureCynosure, Inc. · 2015 · cites it directly21descendants
- K160470SculpSureCynosure, Inc. · 2016 · 2 generations on20descendants
- K171111SculpsureCynosure, Inc. · 2017 · 3 generations on10descendants
- K171992SculpSureCynosure, Inc. · 2017 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K050397 | Velasmooth, Shaper | Syneron Medical, Ltd. | 2005 | — |
| −4 | K053611 | Smoothshapes | Bicellulase, Inc. | 2006 | — |
| −3 | K061603 | Smoothshapes | Biocellulase, Inc. | 2006 | — |
| −2 | K083629 | Smoothshapes | Eleme Medical, Inc. | 2009 | — |
| −1 | K100230 | Smoothshapes System, 11318-120V, 11319-230V | Eleme Medical, Inc. | 2010 | — |
| 0 (this device) | K123971 | Cynosure 1064NM Diode Laser | Cynosure, Inc. | 2013 | — |
| +1 | K150724 | SculpSure | Cynosure, Inc. | 2015 | — |
| +1 | K150230 | SculpSure | Cynosure, Inc. | 2015 | — |
| +2 | K160470 | SculpSure | Cynosure, Inc. | 2016 | — |
| +3 | K171111 | Sculpsure | Cynosure, Inc. | 2017 | — |
| +4 | K171992 | SculpSure | Cynosure, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1996 | 10 | 0 |
| 1997 | 7 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 3 | 0 |
| 2002 | 11 | 0 |
| 2003 | 7 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 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? (3)
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 |
|---|---|---|---|
| * | K083595 | EzlaseSummary page 1…Class II Review Panel: General & Plastic Surgery Predicate Devices (Claiming Substantial Equivalence): Biolase Technology, Inc. ezlaSeTM K083595 CYNOSURE, INC. HILT Family Laser K05 1537 CYNOSURE, INC. SmoothShapes XVO System K 100230 Summary Description o… | 2009 |
| * | K051537 | Hilt Family Laser: Hilt I, Hilt II, Hilt IiiSummary page 2…eral & Plastic Surgery Predicate Devices (Claiming Substantial Equivalence): Biolase Technology, Inc. ezlaSeTM K083595 CYNOSURE, INC. HILT Family Laser K05 1537 CYNOSURE, INC. SmoothShapes XVO System K 100230 Summary Description of the Device: The Cynosure 1064nm Diode Laser is the lase… | 2005 |
| * | K100230 | Smoothshapes System, 11318-120V, 11319-230VSummary page 2…ng Substantial Equivalence): Biolase Technology, Inc. ezlaSeTM K083595 CYNOSURE, INC. HILT Family Laser K05 1537 CYNOSURE, INC. SmoothShapes XVO System K 100230 Summary Description of the Device: The Cynosure 1064nm Diode Laser is the laser device that delivers laser energy in the I 064n… | 2010 |
What descends from it? (25)
See all 254 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?
- The line of descent spans 18 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 5 of the 101 ancestors have a recall of any class.
- Of its descendants, K150724 (Cynosure, Inc., 2015) has gone furthest, with 21 descendants of its own.
- 1 other device also cites its predicate K083595.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
The Cynosure 1064nm Diode Laser Device is intended to provide heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and/or the temporary relaxation of muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123971 · printed Nov 5, 2026
Cite this page
510(k) Report. “K123971: Cynosure 1064NM Diode Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K123971
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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