510(k) · Cleared
ClearedBTL-785W
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 Mar 7, 2022 as substantially equivalent to K193201 (Btl, 2020) and 2 other predicates after a 284-day review. Its family tree reaches back 23 generations to 1995. 7 later devices descend from it.
- Decided
- Mar 7, 2022
- Review
- 284 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 23 generations to K943450 (1995). 287 ancestors in all, the oldest K800617 (1980). 7 later devices descend from it, 2 citing it directly.
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations between
- 3 generations backK182365 TempSure SystemCynosure, Inc. · 2018
- 2 generations backK190678 TempSureCynosure, Inc. · 2019
- 1 generation backK200241 TempSure SystemCynosure, LLC · 2020
- This deviceK211639 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
- Descendant · 4 generations on · 0 of its ownK260945 Ultima System (UL-800);Ultimate Face Package…Fit-Pro KFT (Ltd.) - DBA E-Fit · 2026
- Descendant · 3 generations on · 0 of its ownK253750 BTL-785NEHBTL Industries, Inc. · 2026
Show all 23 generations
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 19 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 18 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 17 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 16 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 15 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 12 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 11 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 10 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 9 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 8 generations backK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
- 7 generations backK102368 Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
- 6 generations backK102698 Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model…Ellman Int'L, Inc. · 2011
- 5 generations backK132665 Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc. · 2013
- 4 generations backK171262 TempSureCynosure, Inc. · 2017
- 3 generations backK182365 TempSure SystemCynosure, Inc. · 2018
- 2 generations backK190678 TempSureCynosure, Inc. · 2019
- 1 generation backK200241 TempSure SystemCynosure, LLC · 2020
- This deviceK211639 BTL-785WBTL Industries, Inc. · 2022
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- 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
- K260945Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape Extension…Fit-Pro KFT (Ltd.) - DBA E-Fit · 2026 · 4 generations on0descendants
- K253750BTL-785NEHBTL Industries, Inc. · 2026 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −22 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −19 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −18 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −17 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −16 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −15 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −12 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −11 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −10 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −9 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| −8 | K101967 | Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' | Ellman Int'L, Inc. | 2010 | — |
| −7 | K102368 | Non-Ablative Wrinkle Treatment Handpiece | Ellman Int'L, Inc. | 2010 | — |
| −6 | K102698 | Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe | Ellman Int'L, Inc. | 2011 | — |
| −5 | K132665 | Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - Iec | Ellman International, Inc. | 2013 | — |
| −4 | K171262 | TempSure | Cynosure, Inc. | 2017 | — |
| −3 | K182365 | TempSure System | Cynosure, Inc. | 2018 | — |
| −2 | K190678 | TempSure | Cynosure, Inc. | 2019 | — |
| −1 | K200241 | TempSure System | Cynosure, LLC | 2020 | — |
| 0 (this device) | 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 | — |
| +4 | K260945 | Ultima System (UL-800);Ultimate Face Package (UL-800-Face-Set);Ultimate Shape… | Fit-Pro KFT (Ltd.) - DBA E-Fit | 2026 | — |
| +3 | K253750 | BTL-785NEH | BTL Industries, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 17 | 0 |
| 1995 | 18 | 0 |
| 1996 | 21 | 0 |
| 1997 | 22 | 0 |
| 1998 | 15 | 0 |
| 1999 | 11 | 0 |
| 2000 | 22 | 0 |
| 2001 | 24 | 0 |
| 2002 | 28 | 0 |
| 2003 | 22 | 0 |
| 2004 | 10 | 0 |
| 2005 | 6 | 0 |
| 2006 | 2 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K193201 | BTL-785FSummary page 6…lly equivalent to the following products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers: ● BTL-785F (K193201) ● EXILIS 5000 (K092191) ● TempSure System, (K200241), FlexSure single-use Applicator Product Description The BTL… | 2020 |
| * | K092191 | Exilis, Model 5000Summary page 6…g products that are already cleared for distribution in the USA under the following 510(k) Premarket Notification numbers: ● BTL-785F (K193201) ● EXILIS 5000 (K092191) ● TempSure System, (K200241), FlexSure single-use Applicator Product Description The BTL-785W is a state-of-the-art ra… | 2009 |
| * | K200241 | TempSure SystemSummary page 6…for distribution in the USA under the following 510(k) Premarket Notification numbers: ● BTL-785F (K193201) ● EXILIS 5000 (K092191) ● TempSure System, (K200241), FlexSure single-use Applicator Product Description The BTL-785W is a state-of-the-art radiofrequency device that enables th… | 2020 |
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 27 years and passes through 10 companies; a new generation was cleared every 9 months on median.
- 14 of the 287 ancestors have a recall of any class.
- Of its descendants, K222556 (BTL Industries, Inc., 2023) has gone furthest, with 5 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. 2022, 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 BTL-785W device has the following indications for use: The BTL-785W with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite. The BTL-785W with BTL-785-2 applicator is indicated to…
Read the full statement (245 words)
The BTL-785W device has the following indications for use:
The BTL-785W with BTL-785-1 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The BTL-785-1-4 massage device is intended to provide a temporary reduction in the appearance of cellulite.
The BTL-785W with BTL-785-2 applicator is indicated to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The BTL-785W with BTL-785-3 applicator is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
The Applicator BTL-785-4 of BTL-785W device used with tips BTL-785-4-1, BTL-785-4-2, BTL-785-4-5 and BTL-785-4-6 is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The Applicator BTL-785-4 of BTL-785F device used with tips BTL-785-4-3, BTL-785-4-4, BTL-785-4-7 and BTL-785-4-8 is intended for dermatological procedures requiring fractional treatment of the skin. At higher energy levels greater than 62 mJ/pin, use of the BTL-785-4 applicator is limited to Skin Types I-IV.
The BTL-785-7 hands-free applicator of BTL-785W used with BTL-785-7-1, BTL-785-7-2, BTL-785-7-3, BTL-785-7-4, BTL-785-7-5, BTL-785-7-6 single use electrodes is intended to provide heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
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/K211639 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211639: BTL-785W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211639
Report an extraction error
Are you the manufacturer?
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