510(k) · Cleared
ClearedtruSculpt
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cutera, Inc. · PBX Massager, Vacuum, Radio Frequency Induced Heat
Cleared on Dec 9, 2016 as substantially equivalent to K133739 (Cutera, Inc., 2014) and 2 other predicates after a 92-day review. Its family tree reaches back 18 generations to 1995. 5 later devices descend from it.
- Decided
- Dec 9, 2016
- Review
- 92 days
- Class
- Class II
- Product code
- PBX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 18 generations to K943450 (1995). 107 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 2 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
- 2 generations backK120510 TranscendSyneron Medical, Ltd. · 2013
- 1 generation backK143559 XP1000 RFBTL Industries, Inc. · 2015
- This deviceK162512 truSculptCutera, Inc. · 2016
- Descendant · cites it directly · 3 of its ownK180709 truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc. · 2018
- Descendant · cites it directly · 3 of its ownK172004 truSculptCutera, Inc. · 2017
- Descendant · 2 generations on · 2 of its ownK221407 truSculpt iDCutera, Inc. · 2022
- Descendant · 3 generations on · 1 of its ownK223110 truSculpt iDCutera, Inc. · 2022
- Descendant · 4 generations on · 0 of its ownK252888 NeoSculpt PlusS&M Medical Co., Ltd. · 2026
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 5 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 4 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 3 generations backK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
- 2 generations backK120510 TranscendSyneron Medical, Ltd. · 2013
- 1 generation backK143559 XP1000 RFBTL Industries, Inc. · 2015
- This deviceK162512 truSculptCutera, Inc. · 2016
Most influential descendants
Showing 5 of 5 · See all- K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc. · 2018 · cites it directly3descendants
- K172004truSculptCutera, Inc. · 2017 · cites it directly3descendants
- K221407truSculpt iDCutera, Inc. · 2022 · 2 generations on2descendants
- K223110truSculpt iDCutera, Inc. · 2022 · 3 generations on1descendant
- K252888NeoSculpt PlusS&M Medical Co., Ltd. · 2026 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −5 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −4 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| −3 | K082622 | Alma Lasers Accent B-Shape Massager Handpiece/Module | Alma Lasers, Ltd. | 2009 | — |
| −2 | K120510 | Transcend | Syneron Medical, Ltd. | 2013 | — |
| −1 | K143559 | XP1000 RF | BTL Industries, Inc. | 2015 | — |
| 0 (this device) | K162512 | truSculpt | Cutera, Inc. | 2016 | — |
| +1 | K180709 | truSculpt RF Device; truSculpt; truSculpt 3D | Cutera, Inc. | 2018 | — |
| +1 | K172004 | truSculpt | Cutera, Inc. | 2017 | — |
| +2 | K221407 | truSculpt iD | Cutera, Inc. | 2022 | — |
| +3 | K223110 | truSculpt iD | Cutera, Inc. | 2022 | — |
| +4 | K252888 | NeoSculpt Plus | S&M Medical Co., Ltd. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 2 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 11 | 0 |
| 1997 | 14 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 9 | 0 |
| 2001 | 6 | 0 |
| 2002 | 9 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 2 | 0 |
| 2026 | 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 PBX? 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 PBX device
- #1 K210877 Evolve System with the T3 Applicatorscore 23.6 · 24 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 |
|---|---|---|---|
| * | K133739 | TrusculptSummary page 4…me: Electrosurgical cutting and coagulation device and accessories, PBX, GEI 21 CFR 878.4400 Legally Marketed Cutera truSculpt RF Device (K133739) Predicate Devices: BTL XP1000 RF (K143559) Syneron Transcend (K120510) Device Description: The tr… | 2014 |
| * | K143559 | XP1000 RFSummary page 4…evice and accessories, PBX, GEI 21 CFR 878.4400 Legally Marketed Cutera truSculpt RF Device (K133739) Predicate Devices: BTL XP1000 RF (K143559) Syneron Transcend (K120510) Device Description: The truSculpt device consists of a console, one or mo… | 2015 |
| * | K120510 | TranscendSummary page 4…21 CFR 878.4400 Legally Marketed Cutera truSculpt RF Device (K133739) Predicate Devices: BTL XP1000 RF (K143559) Syneron Transcend (K120510) Device Description: The truSculpt device consists of a console, one or more RF handpieces that connec… | 2013 |
What descends from it? (5)
2 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 7 companies; a new generation was cleared every 1.2 years on median.
- 4 of the 107 ancestors have a recall of any class.
- Of its descendants, K180709 (Cutera, Inc., 2018) has gone furthest, with 3 descendants of its own.
- 4 other devices also cite its predicate K133739.
How does its category compare?
All PBX devicesPBX Massager, Vacuum, Radio Frequency Induced Heat: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · PBX
7in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · PBX
200in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · PBX
1in 2017
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · PBX
4in 2025
MAUDE reports naming product code PBX, 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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 12 |
| 2014 | 2 | — | 0 | 4 |
| 2015 | 5 | 181 | 0 | 0 |
| 2016 | 7 | 130 | 0 | 2 |
| 2017 | 6 | 132 | 1 | 1 |
| 2018 | 3 | 89 | 0 | 1 |
| 2019 | 8 | 147 | 0 | 4 |
| 2020 | 8 | 134 | 0 | 4 |
| 2021 | 6 | 169 | 0 | 8 |
| 2022 | 7 | 308 | 0 | 7 |
| 2023 | 9 | 227 | 0 | 7 |
| 2024 | 6 | 130 | 0 | 2 |
| 2025 | 7 | 200 | 0 | 4 |
| 2026 | 6 | 225 | 0 | — |
What is it indicated for?
The truSculpt RF energy is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions, such as relief of pain and muscle spasms and increase in local circulation.
Additionally, the 2 MHz setting for the 40 cm2 handpiece is indicated for temporary reduction in circumference of the abdomen.
The truSculpt massage device is intended to provide a temporary reduction in the appearance of cellulite.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K162512 · printed Nov 6, 2026
Cite this page
510(k) Report. “K162512: truSculpt.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K162512
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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