510(k) · Cleared
ClearedThermage Thermacool NXT System and Accessories
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Solta Medical, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 26, 2009 as substantially equivalent to K033942 (Thermage, Inc., 2004) and 12 other predicates after a 115-day review. Its family tree reaches back 16 generations to 1995. 19 later devices descend from it.
- Decided
- Jun 26, 2009
- Review
- 115 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 13
Its longest line of descent runs back 16 generations to K943450 (1995). 109 ancestors in all, the oldest K800617 (1980). 19 later devices descend from it, 4 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 backK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
- This deviceK090580 Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 2009
- Descendant · cites it directly · 17 of its ownK132431 Thermage CPT SystemSolta Medical, Inc. · 2013 · Recalled
- Descendant · cites it directly · 13 of its ownK170758 Thermage FLX System and AccessoriesSolta Medical · 2017
- Descendant · 2 generations on · 2 of its ownK230663 DensityJeisys Medical, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK221989 The OligioWontech Co., Ltd. · 2022
- Descendant · cites it directly · 2 of its ownK173759 Thermage CPT System and AccessoriesSolta Medical · 2018 · Recalled
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 backK082622 Alma Lasers Accent B-Shape Massager Handpiece/ModuleAlma Lasers, Ltd. · 2009
- This deviceK090580 Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 2009
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K132431Thermage CPT SystemSolta Medical, Inc. · 2013 · cites it directly17descendants
- K170758Thermage FLX System and AccessoriesSolta Medical · 2017 · cites it directly13descendants
- K230663DensityJeisys Medical, Inc. · 2023 · 2 generations on2descendants
- K221989The OligioWontech Co., Ltd. · 2022 · 2 generations on2descendants
- K173759Thermage CPT System and AccessoriesSolta Medical · 2018 · cites it directly2descendants
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 | K082622 | Alma Lasers Accent B-Shape Massager Handpiece/Module | Alma Lasers, Ltd. | 2009 | — |
| 0 (this device) | K090580 | Thermage Thermacool NXT System and Accessories | Solta Medical, Inc. | 2009 | — |
| +1 | K132431 | Thermage CPT System | Solta Medical, Inc. | 2013 | 1 |
| +1 | K170758 | Thermage FLX System and Accessories | Solta Medical | 2017 | — |
| +2 | K230663 | Density | Jeisys Medical, Inc. | 2023 | — |
| +2 | K221989 | The Oligio | Wontech Co., Ltd. | 2022 | — |
| +1 | K173759 | Thermage CPT System and Accessories | Solta Medical | 2018 | 1 |
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 | 6 | 0 |
| 2004 | 3 | 0 |
| 2005 | 5 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 4 | 0 |
| 2025 | 7 | 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? (13)
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 |
|---|---|---|---|
| * | K033942 | Thermage Thermacool SystemSummary page 1…Managing Director, Regulatory, Clinical and Quality B. Predicate Devices L~51OkF~otfica IJOn- n Thernage ThermaCool NXT K033942, K032088, K031046, K043402, System K051710, K052778, K072849 Syneron Medical Velasmooth Shaper Shaper… | 2004 |
| * | K032088 | Modification to Thermacool TC SystemSummary page 1…naging Director, Regulatory, Clinical and Quality B. Predicate Devices L~51OkF~otfica IJOn- n Thernage ThermaCool NXT K033942, K032088, K031046, K043402, System K051710, K052778, K072849 Syneron Medical Velasmooth Shaper Shaper ~~… | 2003 |
| * | K031046 | Thermacool TC SystemSummary page 1…rector, Regulatory, Clinical and Quality B. Predicate Devices L~51OkF~otfica IJOn- n Thernage ThermaCool NXT K033942, K032088, K031046, K043402, System K051710, K052778, K072849 Syneron Medical Velasmooth Shaper Shaper ~~~K050397,… | 2003 |
| * | K043402 | Thermage Thermacool SystemSummary page 1…egulatory, Clinical and Quality B. Predicate Devices L~51OkF~otfica IJOn- n Thernage ThermaCool NXT K033942, K032088, K031046, K043402, System K051710, K052778, K072849 Syneron Medical Velasmooth Shaper Shaper ~~~K050397, K070092,… | 2005 |
| * | K051710 | Thermage Thermacool Coupling FluidSummary page 1…redicate Devices L~51OkF~otfica IJOn- n Thernage ThermaCool NXT K033942, K032088, K031046, K043402, System K051710, K052778, K072849 Syneron Medical Velasmooth Shaper Shaper ~~~K050397, K070092, K071872 Alma Uniform Massager… | 2005 |
| * | K052778 | Thermage Thermacool Skin MarketingSummary page 1…Devices L~51OkF~otfica IJOn- n Thernage ThermaCool NXT K033942, K032088, K031046, K043402, System K051710, K052778, K072849 Syneron Medical Velasmooth Shaper Shaper ~~~K050397, K070092, K071872 Alma Uniform Massager K082622 H… | 2005 |
| * | K072849 | Modification to Thermage Thermacool SystemSummary page 1…L~51OkF~otfica IJOn- n Thernage ThermaCool NXT K033942, K032088, K031046, K043402, System K051710, K052778, K072849 Syneron Medical Velasmooth Shaper Shaper ~~~K050397, K070092, K071872 Alma Uniform Massager K082622 Handpiece/… | 2008 |
| * | K050397 | Velasmooth, ShaperSummary page 1…age ThermaCool NXT K033942, K032088, K031046, K043402, System K051710, K052778, K072849 Syneron Medical Velasmooth Shaper Shaper ~~~K050397, K070092, K071872 Alma Uniform Massager K082622 Handpiece/Module Cynosure Triactive Therapeutic Massage System K030876 LPG… | 2005 |
| * | K070092 | Modification to Velasmooth, ShaperSummary page 1…aCool NXT K033942, K032088, K031046, K043402, System K051710, K052778, K072849 Syneron Medical Velasmooth Shaper Shaper ~~~K050397, K070092, K071872 Alma Uniform Massager K082622 Handpiece/Module Cynosure Triactive Therapeutic Massage System K030876 LPG Therapeu… | 2007 |
| * | K071872 | VelashapeSummary page 1…K033942, K032088, K031046, K043402, System K051710, K052778, K072849 Syneron Medical Velasmooth Shaper Shaper ~~~K050397, K070092, K071872 Alma Uniform Massager K082622 Handpiece/Module Cynosure Triactive Therapeutic Massage System K030876 LPG Therapeutic Massa… | 2007 |
| * | K082622 | Alma Lasers Accent B-Shape Massager Handpiece/ModuleSummary page 1…402, System K051710, K052778, K072849 Syneron Medical Velasmooth Shaper Shaper ~~~K050397, K070092, K071872 Alma Uniform Massager K082622 Handpiece/Module Cynosure Triactive Therapeutic Massage System K030876 LPG Therapeutic Massager/Vibrator K990445 C.… | 2009 |
| * | K030876 | Cynosure Triactive Therapeutic Massage SystemSummary page 1…al Velasmooth Shaper Shaper ~~~K050397, K070092, K071872 Alma Uniform Massager K082622 Handpiece/Module Cynosure Triactive Therapeutic Massage System K030876 LPG Therapeutic Massager/Vibrator K990445 C. Device Description The Thermage ThermaCool NXT System delivers capaci… | 2004 |
| * | K990445 | LPG Therapeutic Massager, Models -Esi, Therapeutic Massager/VibratorSummary page 1…K070092, K071872 Alma Uniform Massager K082622 Handpiece/Module Cynosure Triactive Therapeutic Massage System K030876 LPG Therapeutic Massager/Vibrator K990445 C. Device Description The Thermage ThermaCool NXT System delivers capacitively coupled radiofrequency energy while cooling t… | 2000 |
What descends from it? (19)
See all 194 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 6 companies; a new generation was cleared every 9 months on median.
- 3 of the 109 ancestors have a recall of any class.
- Of its descendants, K132431 (Solta Medical, Inc., 2013) has gone furthest, with 17 descendants of its own.
- 7 other devices also cite its predicate K033942.
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 radiofrequency-energy only delivery components of the Thermage ThermaCool NXT System and Accessories are indicated for use in: Dermatologic and general surgical procedures for electrocoagulation and hemostasis; Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; Non-invasive treatment of wrinkles and rhytids. The simultaneous application of radiofrequency energy and skin vibration by the Thermage ThermaCool…
Read the full statement (115 words)
The radiofrequency-energy only delivery components of the Thermage ThermaCool NXT System and Accessories are indicated for use in:
Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids;
Non-invasive treatment of wrinkles and rhytids.
The simultaneous application of radiofrequency energy and skin vibration by the Thermage ThermaCool NXT System and Accessories is indicated for use in:
Dermatologic and general surgical procedures for electrocoagulation and hemostasis;
Non-invasive treatment of periorbital wrinkles and rhytids;
Non-invasive treatment of wrinkles and rhytids;
Temporary improvement in the appearance of cellulite;
Relief of minor muscle aches and pains;
Relief of muscle spasms;
Temporary improvement of local circulation (i.e., blood circulation).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090580: Thermage Thermacool NXT System and Accessories.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090580
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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