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 Sep 26, 2017 as substantially equivalent to K171111 (Cynosure, Inc., 2017) and 1 other predicate after an 85-day review. Its family tree reaches back 23 generations to 1995. 8 later devices descend from it.
- Decided
- Sep 26, 2017
- Review
- 85 days
- Class
- Class II
- Product code
- PKT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 23 generations to K943450 (1995). 186 ancestors in all, the oldest K800617 (1980). 8 later devices descend from it, 3 citing it directly.
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations between
- 3 generations backK160259 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2016
- 2 generations backK162050 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2016
- 1 generation backK171111 SculpsureCynosure, Inc. · 2017
- This deviceK171992 SculpSureCynosure, Inc. · 2017
- Descendant · cites it directly · 5 of its ownK182741 SculpSureCynosure · 2019
- Descendant · 2 generations on · 1 of its ownK220592 Venus BlissMAXVenus Concept USA, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK201731 Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
- Descendant · 3 generations on · 0 of its ownK252845 Venus Nova (FP-2001)Venus Concept, Inc. · 2025
- Descendant · 3 generations on · 0 of its ownK240658 1060nm laser body slimming machineHebei JT Medical Co., Ltd. · 2024
Show all 23 generations
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 19 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 18 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 17 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 16 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 15 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 12 generations backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- 11 generations backK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
- 10 generations backK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- 9 generations backK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- 8 generations backK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- 7 generations backK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
- 6 generations backK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- 5 generations backK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 4 generations backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 3 generations backK160259 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2016
- 2 generations backK162050 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2016
- 1 generation backK171111 SculpsureCynosure, Inc. · 2017
- This deviceK171992 SculpSureCynosure, Inc. · 2017
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K182741SculpSureCynosure · 2019 · cites it directly5descendants
- K220592Venus BlissMAXVenus Concept USA, Inc. · 2022 · 2 generations on1descendant
- K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd. · 2020 · 2 generations on1descendant
- K252845Venus Nova (FP-2001)Venus Concept, Inc. · 2025 · 3 generations on0descendants
- K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd. · 2024 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −22 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −19 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −18 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −17 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −16 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −15 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −12 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| −11 | K051710 | Thermage Thermacool Coupling Fluid | Thermage, Inc. | 2005 | — |
| −10 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| −9 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| −8 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| −7 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
| −6 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
| −5 | K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −4 | K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −3 | K160259 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016 | — |
| −2 | K162050 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016 | — |
| −1 | K171111 | Sculpsure | Cynosure, Inc. | 2017 | — |
| 0 (this device) | K171992 | SculpSure | Cynosure, Inc. | 2017 | — |
| +1 | K182741 | SculpSure | Cynosure | 2019 | — |
| +2 | K220592 | Venus BlissMAX | Venus Concept USA, Inc. | 2022 | — |
| +2 | K201731 | Diode Laser Body Sculpture System | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| +3 | K252845 | Venus Nova (FP-2001) | Venus Concept, Inc. | 2025 | — |
| +3 | K240658 | 1060nm laser body slimming machine | Hebei JT Medical Co., Ltd. | 2024 | — |
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 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K171111 | SculpsureSummary page 4…II Product Code(s) PKT 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed Cynosure SculpSure K171111, Zeltiq Coolsculpting K162050 Predicate Devices The predicate devices have not been subject to a design-related… | 2017 |
| * | K162050 | ZELTIQ CoolSculpting SystemSummary page 4…PKT 807.92 (a)(3) Legally marketed device(s) to which equivalence is claimed Cynosure SculpSure K171111, Zeltiq Coolsculpting K162050 Predicate Devices The predicate devices have not been subject to a design-related recall… | 2016 |
What descends from it? (8)
3 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 22 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 6 of the 186 ancestors have a recall of any class.
- Of its descendants, K182741 (Cynosure, 2019) has gone furthest, with 5 descendants of its own.
- 1 other device also cites its predicate K171111.
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. 2017, 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?
The Cynosure SculpSure™ is intended for non-invasive lipolysis of the abdomen, flanks, back, and thighs in individuals
with a Body Mass Index (BMI) of 30 or less. In addition, the device is intended for non-invasive lipolysis of the
submental area in individuals with a BMI of 43 or less. The device is intended to affect the appearance of visible fat
bulges in the abdomen, flanks, back, thighs and submental area.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171992 · printed Nov 4, 2026
Cite this page
510(k) Report. “K171992: SculpSure.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K171992
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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