510(k) · Cleared
ClearedExilis, Model 5000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Btl Industries, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Nov 25, 2009 as substantially equivalent to K083590 (Iskra Medical, D.O.O., 2009) and 5 other predicates after a 127-day review. Its family tree reaches back 16 generations to 1995. 12 later devices descend from it.
- Decided
- Nov 25, 2009
- Review
- 127 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 16 generations to K943450 (1995). 89 ancestors in all, the oldest K800617 (1980). 12 later devices descend from it, 5 citing it directly.
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations between
- 3 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 2 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 1 generation backK083590 Iskra Medical Green Irf PrestigeIskra Medical, D.O.O. · 2009
- This deviceK092191 Exilis, Model 5000Btl Industries, Ltd. · 2009
- Descendant · cites it directly · 8 of its ownK193201 BTL-785FBtl · 2020
- Descendant · cites it directly · 7 of its ownK211639 BTL-785WBTL Industries, Inc. · 2022
- Descendant · cites it directly · 5 of its ownK222556 BTL-785XBTL Industries, Inc. · 2023
- Descendant · 2 generations on · 3 of its ownK233604 BTL-785SBTL Industries, Inc. · 2024
- Descendant · 3 generations on · 1 of its ownK242532 BTL-785BNF-EBTL Industries, Inc. · 2024
Show all 16 generations
- Root · 16 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 14 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 12 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 11 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 10 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 9 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 8 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 7 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 5 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 4 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 3 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 2 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 1 generation backK083590 Iskra Medical Green Irf PrestigeIskra Medical, D.O.O. · 2009
- This deviceK092191 Exilis, Model 5000Btl Industries, Ltd. · 2009
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K193201BTL-785FBtl · 2020 · cites it directly8descendants
- K211639BTL-785WBTL Industries, Inc. · 2022 · cites it directly7descendants
- K222556BTL-785XBTL Industries, Inc. · 2023 · cites it directly5descendants
- K233604BTL-785SBTL Industries, Inc. · 2024 · 2 generations on3descendants
- K242532BTL-785BNF-EBTL Industries, Inc. · 2024 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −15 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −14 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −12 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −11 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −10 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −9 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −8 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −7 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −5 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −4 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −3 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −2 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| −1 | K083590 | Iskra Medical Green Irf Prestige | Iskra Medical, D.O.O. | 2009 | — |
| 0 (this device) | K092191 | Exilis, Model 5000 | Btl Industries, Ltd. | 2009 | — |
| +1 | K193201 | BTL-785F | Btl | 2020 | — |
| +1 | K211639 | BTL-785W | BTL Industries, Inc. | 2022 | — |
| +1 | K222556 | BTL-785X | BTL Industries, Inc. | 2023 | — |
| +2 | K233604 | BTL-785S | BTL Industries, Inc. | 2024 | — |
| +3 | K242532 | BTL-785BNF-E | BTL Industries, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 13 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 5 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 3 | 0 |
| 2026 | 3 | 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? (6)
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 |
|---|---|---|---|
| * | K083590 | Iskra Medical Green Irf PrestigeSummary page 1…Cutting & Coagulation Device & Accessories Classification Regulation: 878.4400 Product Code: GEI Predicate Devices e Iskra Medical - Iskra Medical Green IRF Prestige K083590; copy of 510(k) clearance letter in Appendix 5-A ¢ Thermage, Inc. - Thermage ThermaCool System K053365, K040135, K033942; copies… | 2009 |
| * | K053365 | Modification to Thermage Thermacool SystemSummary page 1…icate Devices e Iskra Medical - Iskra Medical Green IRF Prestige K083590; copy of 510(k) clearance letter in Appendix 5-A ¢ Thermage, Inc. - Thermage ThermaCool System K053365, K040135, K033942; copies of 510(k) clearance letters in Appendix 5-B through 5-D respectively ¢ Alma Lasers — Accent™ K072699,… | 2005 |
| * | K040135 | Thermage Thermacool SystemSummary page 1…ices e Iskra Medical - Iskra Medical Green IRF Prestige K083590; copy of 510(k) clearance letter in Appendix 5-A ¢ Thermage, Inc. - Thermage ThermaCool System K053365, K040135, K033942; copies of 510(k) clearance letters in Appendix 5-B through 5-D respectively ¢ Alma Lasers — Accent™ K072699, K070004;… | 2004 |
| * | K033942 | Thermage Thermacool SystemSummary page 1…skra Medical - Iskra Medical Green IRF Prestige K083590; copy of 510(k) clearance letter in Appendix 5-A ¢ Thermage, Inc. - Thermage ThermaCool System K053365, K040135, K033942; copies of 510(k) clearance letters in Appendix 5-B through 5-D respectively ¢ Alma Lasers — Accent™ K072699, K070004; copies of… | 2004 |
| * | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent, Accent XLSummary page 1…ermage, Inc. - Thermage ThermaCool System K053365, K040135, K033942; copies of 510(k) clearance letters in Appendix 5-B through 5-D respectively ¢ Alma Lasers — Accent™ K072699, K070004; copies of 510(k) clearance letters in Appendix 5-E through Appendix 5-F respectively 6. Device Descrip… | 2007 |
| * | K070004 | AccentSummary page 1…nc. - Thermage ThermaCool System K053365, K040135, K033942; copies of 510(k) clearance letters in Appendix 5-B through 5-D respectively ¢ Alma Lasers — Accent™ K072699, K070004; copies of 510(k) clearance letters in Appendix 5-E through Appendix 5-F respectively 6. Device Description The… | 2007 |
What descends from it? (12)
See all 125 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 14 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 3 of the 89 ancestors have a recall of any class.
- Of its descendants, K193201 (Btl, 2020) has gone furthest, with 8 descendants of its own.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 EXILIS device is indicated for the primary treatment of dermatologic and general surgical procedures for non-invasive treatment of wrinkles and rhytids. EXILIS is a state-of-the-art device to apply therapy by a non-invasive method of high-frequency field.
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/K092191 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092191: Exilis, Model 5000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092191
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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