510(k) · Cleared
ClearedDiode Laser Body Sculpture System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shanghai Apolo Medical Technology Co., Ltd. · PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Cleared on Sep 10, 2020 as substantially equivalent to K182741 (Cynosure, 2019) and 1 other predicate after a 78-day review. Its family tree reaches back 25 generations to 1995. 1 later device descends from it.
- Decided
- Sep 10, 2020
- Review
- 78 days
- Class
- Class II
- Product code
- PKT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 25 generations to K943450 (1995). 191 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations between
- 3 generations backK171111 SculpsureCynosure, Inc. · 2017
- 2 generations backK171992 SculpSureCynosure, Inc. · 2017
- 1 generation backK182741 SculpSureCynosure · 2019
- This deviceK201731 Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
- Descendant · cites it directly · 0 of its ownK240658 1060nm laser body slimming machineHebei JT Medical Co., Ltd. · 2024
Show all 25 generations
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 24 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 21 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 20 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 19 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 18 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 17 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 14 generations backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- 13 generations backK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
- 12 generations backK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- 11 generations backK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- 10 generations backK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- 9 generations backK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
- 8 generations backK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- 7 generations backK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 6 generations backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 5 generations backK160259 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2016
- 4 generations backK162050 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2016
- 3 generations backK171111 SculpsureCynosure, Inc. · 2017
- 2 generations backK171992 SculpSureCynosure, Inc. · 2017
- 1 generation backK182741 SculpSureCynosure · 2019
- This deviceK201731 Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
Most influential descendants
Showing 1 of 1 · See all- K2406581060nm laser body slimming machineHebei JT Medical Co., Ltd. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −24 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −21 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −20 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −19 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −18 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −17 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −14 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| −13 | K051710 | Thermage Thermacool Coupling Fluid | Thermage, Inc. | 2005 | — |
| −12 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| −11 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| −10 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| −9 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
| −8 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
| −7 | K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −6 | K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −5 | K160259 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016 | — |
| −4 | K162050 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016 | — |
| −3 | K171111 | Sculpsure | Cynosure, Inc. | 2017 | — |
| −2 | K171992 | SculpSure | Cynosure, Inc. | 2017 | — |
| −1 | K182741 | SculpSure | Cynosure | 2019 | — |
| 0 (this device) | K201731 | Diode Laser Body Sculpture System | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| +1 | 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 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K182741 | SculpSureSummary page 4…00 Regulatory Class: Class II Product code: PKT Review Panel General & Plastic Surgery III Predicate Devices 510(k) Number: K182741 Trade name: SculpSure Common name: Low Level Laser System for Aesthetic Use Classification:… | 2019 |
| * | K191068 | Powersculp laser lipolysis systemSummary page 4…Low Level Laser System for Aesthetic Use Classification: Class II Product Code: PKT Manufacturer Cynosure 510(k) Number: K191068 Trade name: Powersculp laser lipolysis system Common name: Low Level Laser System for Aesthetic Use Cl… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240658 | 1060nm laser body slimming machine | 2024 | 0 |
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 25 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 6 of the 191 ancestors have a recall of any class.
- Of its descendants, K240658 (Hebei JT Medical Co., Ltd., 2024) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K182741.
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. 2020, 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 Diode Laser Body Sculpture Systems 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. The device is intended to affect the appearance of visible fat bulges in the abdomen, flanks, back, and thighs.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K201731 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201731: Diode Laser Body Sculpture System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201731
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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