510(k) · Cleared
ClearedBodySculp
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rohrer Aesthetics, LLC · PKT Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Cleared on Nov 9, 2021 as substantially equivalent to K191068 (Wuhan Lotuxs Technology Co., Ltd., 2019) after a 105-day review. Its family tree reaches back 22 generations to 1995. 1 later device descends from it.
- Decided
- Nov 9, 2021
- Review
- 105 days
- Class
- Class II
- Product code
- PKT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 22 generations to K943450 (1995). 184 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 2 generations backK160470 SculpSureCynosure, Inc. · 2016
- 1 generation backK191068 Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd. · 2019
- This deviceK212331 BodySculpRohrer Aesthetics, LLC · 2021
- Descendant · cites it directly · 0 of its ownK233099 GladiatorRohrer Aesthetics, LLC · 2024
Show all 22 generations
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 18 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 17 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 16 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 15 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 14 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 11 generations backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- 10 generations backK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
- 9 generations backK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- 8 generations backK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- 7 generations backK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- 6 generations backK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
- 5 generations backK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- 4 generations backK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 3 generations backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 2 generations backK160470 SculpSureCynosure, Inc. · 2016
- 1 generation backK191068 Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd. · 2019
- This deviceK212331 BodySculpRohrer Aesthetics, LLC · 2021
Most influential descendants
Showing 1 of 1 · See all- K233099GladiatorRohrer Aesthetics, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −21 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −18 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −17 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −16 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −15 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −14 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −11 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| −10 | K051710 | Thermage Thermacool Coupling Fluid | Thermage, Inc. | 2005 | — |
| −9 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| −8 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| −7 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| −6 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
| −5 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
| −4 | K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −3 | K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −2 | K160470 | SculpSure | Cynosure, Inc. | 2016 | — |
| −1 | K191068 | Powersculp laser lipolysis system | Wuhan Lotuxs Technology Co., Ltd. | 2019 | — |
| 0 (this device) | K212331 | BodySculp | Rohrer Aesthetics, LLC | 2021 | — |
| +1 | K233099 | Gladiator | Rohrer Aesthetics, LLC | 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 |
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? (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 |
|---|---|---|---|
| * | K191068 | Powersculp laser lipolysis systemSummary page 4…uption Of Adipocyte Cells For Aesthetic Use Legally Marketed Predicate PowerSculp (Wuhan Lotuxs Technology Co, Ltd.) Devices: Predicate 510(K) number: K191068 Regulatory Class: Class II Prescription Use Description of the BodySculp The BodySculp is a diode laser sy… | 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 |
|---|---|---|---|
| K233099 | Gladiator | 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 26 years and passes through 8 companies; a new generation was cleared every 1.0 years on median.
- 6 of the 184 ancestors have a recall of any class.
- Of its descendants, K233099 (Rohrer Aesthetics, LLC, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K191068.
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. 2021, 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 Bodysculp laser lipolysis system is intended for non-invasive lipolysis of the flank and abdomen to achieve disruption of adipocyte cells intended for non-invasive aesthetic use to achieve a desired aesthetic affect. This treatment is intended for individuals with a Body Mass Index (BMI) of 30 or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K212331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K212331: BodySculp.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K212331
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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