510(k) · Cleared
ClearedThermage Thermacool System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermage, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jan 14, 2005 as substantially equivalent to K040135 (Thermage, Inc., 2004) and 6 other predicates after a 35-day review. Its family tree reaches back 12 generations to 1995. 124 later devices descend from it.
- Decided
- Jan 14, 2005
- Review
- 35 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 12 generations to K943450 (1995). 28 ancestors in all, the oldest K800617 (1980). 124 later devices descend from it, 3 citing it directly.
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 8 generations between
- 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 1 generation backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- This deviceK043402 Thermage Thermacool SystemThermage, Inc. · 2005
- Descendant · cites it directly · 103 of its ownK052936 Thermage Thermacool SystemThermage, Inc. · 2007
- Descendant · 2 generations on · 102 of its ownK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
- Descendant · 3 generations on · 64 of its ownK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- Descendant · 4 generations on · 57 of its ownK130501 IntensifEndymed Medical, Ltd. · 2014
- Descendant · 5 generations on · 38 of its ownK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018
Show all 12 generations
- Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 8 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 7 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 6 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 5 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 4 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 1 generation backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- This deviceK043402 Thermage Thermacool SystemThermage, Inc. · 2005
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 124 · See all- K052936Thermage Thermacool SystemThermage, Inc. · 2007 · cites it directly103descendants
- K073572Matrix RF ApplicatorSyneron Medical, Ltd. · 2008 · 2 generations on102descendants
- K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011 · 3 generations on64descendants
- K130501IntensifEndymed Medical, Ltd. · 2014 · 4 generations on57descendants
- K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018 · 5 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −11 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −8 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −7 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −6 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −5 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −4 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −3 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −2 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −1 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| 0 (this device) | K043402 | Thermage Thermacool System | Thermage, Inc. | 2005 | — |
| +1 | K052936 | Thermage Thermacool System | Thermage, Inc. | 2007 | — |
| +2 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
| +3 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| +4 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| +5 | K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD, Ltd. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 5 | 0 |
| 2019 | 2 | 0 |
| 2020 | 7 | 0 |
| 2021 | 8 | 0 |
| 2022 | 11 | 0 |
| 2023 | 8 | 0 |
| 2024 | 23 | 0 |
| 2025 | 21 | 0 |
| 2026 | 12 | 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? (7)
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 |
|---|---|---|---|
| * | K040135 | Thermage Thermacool SystemSummary page 1…ol TC System and Accessories: Device Premarket Notification ThermaCool System K040135, Cleared 6/21/04 ThermaCool System K033942, Cleared 2/4/04 ThermaCool TC Sys… | 2004 |
| * | K033942 | Thermage Thermacool SystemSummary page 1…Premarket Notification ThermaCool System K040135, Cleared 6/21/04 ThermaCool System K033942, Cleared 2/4/04 ThermaCool TC System (Model TC) K021402, Cleared 11/5/02 ThermaCool TC Syst… | 2004 |
| * | K021402 | Thermage Thermacool TC SystemSummary page 1…K040135, Cleared 6/21/04 ThermaCool System K033942, Cleared 2/4/04 ThermaCool TC System (Model TC) K021402, Cleared 11/5/02 ThermaCool TC System (Model TC) K013639, Cleared 1/29/02 Thermage ThermaCo… | 2002 |
| * | K013639 | Thermage Thermacool TC SystemSummary page 1…K033942, Cleared 2/4/04 ThermaCool TC System (Model TC) K021402, Cleared 11/5/02 ThermaCool TC System (Model TC) K013639, Cleared 1/29/02 Thermage ThermaCool IIA System K013034, Cleared 10/4/01 Thermage ThermaCo… | 2002 |
| * | K013034 | Modification to: Thermacool IiaSummary page 1…K021402, Cleared 11/5/02 ThermaCool TC System (Model TC) K013639, Cleared 1/29/02 Thermage ThermaCool IIA System K013034, Cleared 10/4/01 Thermage ThermaCool il System K003183, Cleared 12/8/00 Thermage ThermaCo… | 2001 |
| * | K003183 | Thermage Thermacool II SystemSummary page 1…K013639, Cleared 1/29/02 Thermage ThermaCool IIA System K013034, Cleared 10/4/01 Thermage ThermaCool il System K003183, Cleared 12/8/00 Thermage ThermaCool System K000944, Cleared 7/19/00 C. Device Desc… | 2000 |
| * | K000944 | Thermage Thermacool SystemSummary page 1…K013034, Cleared 10/4/01 Thermage ThermaCool il System K003183, Cleared 12/8/00 Thermage ThermaCool System K000944, Cleared 7/19/00 C. Device Description The Thermage ThermaCool System consists of the following co… | 2000 |
What descends from it? (124)
See all 1243 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 10 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 3 of the 28 ancestors have a recall of any class.
- Of its descendants, K052936 (Thermage, Inc., 2007) has gone furthest, with 103 descendants of its own.
- 5 other devices also cite its predicate K040135.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Thermage ThermaCool System is indicated for use in:
The Thermage ThermaCool System 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 facial wrinkles and rhytids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043402 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043402: Thermage Thermacool System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043402
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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