510(k) · Cleared
ClearedSculpSure
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Cleared on Jul 21, 2016 as substantially equivalent to K150724 (Cynosure, Inc., 2015) and 2 other predicates after a 153-day review. Its family tree reaches back 20 generations to 1995. 20 later devices descend from it.
- Decided
- Jul 21, 2016
- Review
- 153 days
- Class
- Class II
- Product code
- PKT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 20 generations to K943450 (1995). 182 ancestors in all, the oldest K800617 (1980). 20 later devices descend from it, 4 citing it directly.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- 2 generations backK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 1 generation backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- This deviceK160470 SculpSureCynosure, Inc. · 2016
- Descendant · cites it directly · 10 of its ownK171111 SculpsureCynosure, Inc. · 2017
- Descendant · 2 generations on · 8 of its ownK171992 SculpSureCynosure, Inc. · 2017
- Descendant · cites it directly · 6 of its ownK191068 Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd. · 2019
- Descendant · 3 generations on · 5 of its ownK182741 SculpSureCynosure · 2019
- Descendant · cites it directly · 4 of its ownK190743 Venus BlissVenus Concept USA, Inc. · 2019
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- 8 generations backK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
- 7 generations backK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- 6 generations backK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- 5 generations backK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- 4 generations backK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
- 3 generations backK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- 2 generations backK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 1 generation backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- This deviceK160470 SculpSureCynosure, Inc. · 2016
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K171111SculpsureCynosure, Inc. · 2017 · cites it directly10descendants
- K171992SculpSureCynosure, Inc. · 2017 · 2 generations on8descendants
- K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd. · 2019 · cites it directly6descendants
- K182741SculpSureCynosure · 2019 · 3 generations on5descendants
- K190743Venus BlissVenus Concept USA, Inc. · 2019 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| −8 | K051710 | Thermage Thermacool Coupling Fluid | Thermage, Inc. | 2005 | — |
| −7 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| −6 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| −5 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| −4 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
| −3 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
| −2 | K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −1 | K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| 0 (this device) | K160470 | SculpSure | Cynosure, Inc. | 2016 | — |
| +1 | K171111 | Sculpsure | Cynosure, Inc. | 2017 | — |
| +2 | K171992 | SculpSure | Cynosure, Inc. | 2017 | — |
| +1 | K191068 | Powersculp laser lipolysis system | Wuhan Lotuxs Technology Co., Ltd. | 2019 | — |
| +3 | K182741 | SculpSure | Cynosure | 2019 | — |
| +1 | K190743 | Venus Bliss | Venus Concept USA, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 6 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 15 | 0 |
| 1997 | 15 | 0 |
| 1998 | 12 | 0 |
| 1999 | 7 | 0 |
| 2000 | 13 | 0 |
| 2001 | 4 | 0 |
| 2002 | 15 | 0 |
| 2003 | 11 | 0 |
| 2004 | 8 | 0 |
| 2005 | 4 | 0 |
| 2006 | 3 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 PKT? 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 PKT device
- #1 K240658 1060nm laser body slimming machinescore 14.8 · 26 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 |
|---|---|---|---|
| * | K150724 | SculpSureSummary page 6…II Product Code(s) PKT 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed CynoSure SculpSure K150724, K150230 Zeltiq Coolsculpting K151179 Predicate Devices The predicate d… | 2015 |
| * | K150230 | SculpSureSummary page 6…II Product Code(s) PKT 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed CynoSure SculpSure K150724, K150230 Zeltiq Coolsculpting K151179 Predicate Devices The predicate devices ha… | 2015 |
| * | K151179 | ZELTIQ CoolSculpting SystemSummary page 6…lly marketed device(s) to which equivalence is claimed CynoSure SculpSure K150724, K150230 Zeltiq Coolsculpting K151179 Predicate Devices The predicate devices have not been subject to a design-related… | 2015 |
What descends from it? (20)
See all 204 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 21 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 6 of the 182 ancestors have a recall of any class.
- Of its descendants, K171111 (Cynosure, Inc., 2017) has gone furthest, with 10 descendants of its own.
How does its category compare?
All PKT devicesPKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PKT
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · PKT
85in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PKT
No recall names PKT since 2007.
Adverse event reports per year · PKT
5in 2025
MAUDE reports naming product code PKT, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 1 | — | 0 | 7 |
| 2017 | 2 | — | 0 | 10 |
| 2018 | 0 | — | 0 | 16 |
| 2019 | 3 | 97 | 0 | 13 |
| 2020 | 2 | — | 0 | 5 |
| 2021 | 2 | — | 0 | 6 |
| 2022 | 2 | — | 0 | 4 |
| 2023 | 3 | 85 | 0 | 0 |
| 2024 | 2 | — | 0 | 4 |
| 2025 | 0 | — | 0 | 5 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Cynosure SculpSure is a diode laser system intended for non-invasive lipolysis of the abdomen and flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the abdomen and flanks.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160470 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160470: SculpSure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160470
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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