510(k) · Cleared
ClearedBTL-499
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 Apr 23, 2024 as substantially equivalent to K230467 (BTL Industries, Inc., 2023) and 1 other predicate after a 140-day review. Its family tree reaches back 25 generations to 1995.
- Decided
- Apr 23, 2024
- Review
- 140 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 25 generations to K943450 (1995). 311 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations between
- 3 generations backK200241 TempSure SystemCynosure, LLC · 2020
- 2 generations backK211639 BTL-785WBTL Industries, Inc. · 2022
- 1 generation backK222556 BTL-785XBTL Industries, Inc. · 2023
- This deviceK233849 BTL-499BTL Industries, Inc. · 2024
Show all 25 generations
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 24 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 21 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 20 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 19 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 18 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 17 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 14 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 13 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 12 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 11 generations backK072699 Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models…Alma Lasers, Ltd. · 2007
- 10 generations backK101967 Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve'Ellman Int'L, Inc. · 2010
- 9 generations backK102368 Non-Ablative Wrinkle Treatment HandpieceEllman Int'L, Inc. · 2010
- 8 generations backK102698 Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model…Ellman Int'L, Inc. · 2011
- 7 generations backK132665 Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - IecEllman International, Inc. · 2013
- 6 generations backK171262 TempSureCynosure, Inc. · 2017
- 5 generations backK182365 TempSure SystemCynosure, Inc. · 2018
- 4 generations backK190678 TempSureCynosure, Inc. · 2019
- 3 generations backK200241 TempSure SystemCynosure, LLC · 2020
- 2 generations backK211639 BTL-785WBTL Industries, Inc. · 2022
- 1 generation backK222556 BTL-785XBTL Industries, Inc. · 2023
- This deviceK233849 BTL-499BTL Industries, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −24 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −21 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −20 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −19 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −18 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −17 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −14 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −13 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −12 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −11 | K072699 | Alma Lasers Family of Accent Radiofrequency (RF) Systems, Models: Accent… | Alma Lasers, Ltd. | 2007 | — |
| −10 | K101967 | Non-Ablative Wrinkle Treatent Handpiece Modle Pelleve' | Ellman Int'L, Inc. | 2010 | — |
| −9 | K102368 | Non-Ablative Wrinkle Treatment Handpiece | Ellman Int'L, Inc. | 2010 | — |
| −8 | K102698 | Pelleve Glidesafe Non-Ablative Wrinkle Treatment System Model Pelleve Glidesafe | Ellman Int'L, Inc. | 2011 | — |
| −7 | K132665 | Pelleve Glidesafe 10MM, 15MM & 20MM Handpiece, Pelleve S5 - Iec | Ellman International, Inc. | 2013 | — |
| −6 | K171262 | TempSure | Cynosure, Inc. | 2017 | — |
| −5 | K182365 | TempSure System | Cynosure, Inc. | 2018 | — |
| −4 | K190678 | TempSure | Cynosure, Inc. | 2019 | — |
| −3 | K200241 | TempSure System | Cynosure, LLC | 2020 | — |
| −2 | K211639 | BTL-785W | BTL Industries, Inc. | 2022 | — |
| −1 | K222556 | BTL-785X | BTL Industries, Inc. | 2023 | — |
| 0 (this device) | K233849 | BTL-499 | BTL Industries, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 6 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 17 | 0 |
| 1995 | 18 | 0 |
| 1996 | 22 | 0 |
| 1997 | 23 | 0 |
| 1998 | 15 | 0 |
| 1999 | 11 | 0 |
| 2000 | 23 | 0 |
| 2001 | 25 | 0 |
| 2002 | 29 | 0 |
| 2003 | 23 | 0 |
| 2004 | 11 | 0 |
| 2005 | 7 | 0 |
| 2006 | 3 | 0 |
| 2007 | 7 | 0 |
| 2008 | 3 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 3 | 0 |
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (2)
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 |
|---|---|---|---|
| * | K230467 | BTL-899FSummary page 5…eady cleared for distribution in the USA under the following 510(k) Premarket Notification numbers: BTL-899F Original 510(k) Sponsor: BTL Industries, Inc. 510(k) Number: K230467 BTL-785X BTL-785-1 applicator and BTL-785-1-4 attachment Original 510(k) Sponsor: BTL Industries Inc. 510(k) Number: K222556 P… | 2023 |
| * | K222556 | BTL-785XSummary page 5…ponsor: BTL Industries, Inc. 510(k) Number: K230467 BTL-785X BTL-785-1 applicator and BTL-785-1-4 attachment Original 510(k) Sponsor: BTL Industries Inc. 510(k) Number: K222556 Product Description The BTL-499 is a non-invasive therapeutic device. The device is comprised of a main unit and applicators t… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 29 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 14 of the 311 ancestors have a recall of any class.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
BTL-499 is indicated to be used for: Non-invasive lipolysis (breakdown of fat) of the abdomen. Reduction in circumference of the abdomen. Non-invasive lipolysis (breakdown of fat) of the thighs. Reduction in circumference of the thighs. BTL-499 is intended for use with skin types I - VI. Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I - IV. Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types…
Read the full statement (129 words)
BTL-499 is indicated to be used for:
Non-invasive lipolysis (breakdown of fat) of the abdomen.
Reduction in circumference of the abdomen.
Non-invasive lipolysis (breakdown of fat) of the thighs.
Reduction in circumference of the thighs.
BTL-499 is intended for use with skin types I - VI.
Non-invasive lipolysis (breakdown of fat) of the flanks limited to skin types I - IV.
Non-invasive lipolysis (breakdown of fat) of the upper arms limited to skin types II and III and BMI 30 and under.
The BTL-499 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-499 massage function 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/K233849 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233849: BTL-499.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233849
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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