510(k) · Cleared
ClearedXP1000 RF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 11, 2015 as substantially equivalent to K120510 (Syneron Medical, Ltd., 2013) after a 177-day review. Its family tree reaches back 17 generations to 1995. 7 later devices descend from it.
- Decided
- Jun 11, 2015
- Review
- 177 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 17 generations to K943450 (1995). 104 ancestors in all, the oldest K800617 (1980). 7 later devices descend from it, 2 citing it directly.
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations between
- 3 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 2 generations backK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
- 1 generation backK120510 TranscendSyneron Medical, Ltd. · 2013
- This deviceK143559 XP1000 RFBTL Industries, Inc. · 2015
- Descendant · cites it directly · 5 of its ownK162512 truSculptCutera, Inc. · 2016
- Descendant · 2 generations on · 3 of its ownK180709 truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc. · 2018
- Descendant · 2 generations on · 3 of its ownK172004 truSculptCutera, Inc. · 2017
- Descendant · 3 generations on · 2 of its ownK221407 truSculpt iDCutera, Inc. · 2022
- Descendant · 4 generations on · 1 of its ownK223110 truSculpt iDCutera, Inc. · 2022
Show all 17 generations
- Root · 17 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 13 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 12 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 11 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 10 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 9 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 6 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 5 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 4 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 3 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 2 generations backK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
- 1 generation backK120510 TranscendSyneron Medical, Ltd. · 2013
- This deviceK143559 XP1000 RFBTL Industries, Inc. · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K162512truSculptCutera, Inc. · 2016 · cites it directly5descendants
- K180709truSculpt RF Device; truSculpt; truSculpt 3DCutera, Inc. · 2018 · 2 generations on3descendants
- K172004truSculptCutera, Inc. · 2017 · 2 generations on3descendants
- K221407truSculpt iDCutera, Inc. · 2022 · 3 generations on2descendants
- K223110truSculpt iDCutera, Inc. · 2022 · 4 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −16 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −13 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −12 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −11 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −10 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −9 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −6 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −5 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −4 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −3 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| −2 | K082622 | Alma Lasers Accent B-Shape Massager Handpiece/Module | Alma Lasers, Ltd. | 2009 | — |
| −1 | K120510 | Transcend | Syneron Medical, Ltd. | 2013 | — |
| 0 (this device) | K143559 | XP1000 RF | BTL Industries, Inc. | 2015 | — |
| +1 | K162512 | truSculpt | Cutera, Inc. | 2016 | — |
| +2 | K180709 | truSculpt RF Device; truSculpt; truSculpt 3D | Cutera, Inc. | 2018 | — |
| +2 | K172004 | truSculpt | Cutera, Inc. | 2017 | — |
| +3 | K221407 | truSculpt iD | Cutera, Inc. | 2022 | — |
| +4 | K223110 | truSculpt iD | Cutera, Inc. | 2022 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 2 | 0 |
| 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 GEI? 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 GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 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 |
|---|---|---|---|
| * | K120510 | TranscendSummary page 4…equivalent to the current product that is already cleared for USA distribution under the following 510(k) Premarket Notification number: • Transcend System (K120510) 5-1… | 2013 |
What descends from it? (7)
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 20 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 3 of the 104 ancestors have a recall of any class.
- Of its descendants, K162512 (Cutera, Inc., 2016) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K120510.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, 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 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The XP1000 RF device is indicated for temporary reduction in circumference of the abdomen.
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/K143559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K143559: XP1000 RF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K143559
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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