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 Feb 4, 2004 as substantially equivalent to K021402 (Thermage, Inc., 2002) and 5 other predicates after a 47-day review. Its family tree reaches back 11 generations to 1995. 527 later devices descend from it.
- Decided
- Feb 4, 2004
- Review
- 47 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 11 generations to K943450 (1995). 26 ancestors in all, the oldest K800617 (1980). 527 later devices descend from it, 8 citing it directly.
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 7 generations between
- 3 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 1 generation backK030142 Thermacool TC SystemThermage, Inc. · 2003
- This deviceK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- Descendant · cites it directly · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- Descendant · 2 generations on · 297 of its ownK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- Descendant · 3 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 4 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · cites it directly · 181 of its ownK070004 AccentAlma Lasers, Ltd. · 2007
Show all 11 generations
- Root · 11 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 9 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 7 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 6 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 5 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 4 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 3 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 2 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 1 generation backK030142 Thermacool TC SystemThermage, Inc. · 2003
- This deviceK033942 Thermage Thermacool SystemThermage, Inc. · 2004
Showing 5 of 527 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 527 · See all- K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · cites it directly476descendants
- K060448Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006 · 2 generations on297descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 3 generations on266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 4 generations on198descendants
- K070004AccentAlma Lasers, Ltd. · 2007 · cites it directly181descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −10 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −9 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −7 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −6 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −5 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −4 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −3 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −2 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −1 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| 0 (this device) | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| +1 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| +2 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| +3 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +4 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +1 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 8 | 0 |
| 2009 | 10 | 0 |
| 2010 | 8 | 0 |
| 2011 | 11 | 0 |
| 2012 | 10 | 0 |
| 2013 | 11 | 0 |
| 2014 | 21 | 0 |
| 2015 | 21 | 0 |
| 2016 | 31 | 0 |
| 2017 | 31 | 0 |
| 2018 | 28 | 0 |
| 2019 | 20 | 0 |
| 2020 | 33 | 0 |
| 2021 | 32 | 0 |
| 2022 | 49 | 0 |
| 2023 | 41 | 0 |
| 2024 | 60 | 0 |
| 2025 | 56 | 0 |
| 2026 | 38 | 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 |
|---|---|---|---|
| * | K021402 | Thermage Thermacool TC SystemSummary page 1…ThermaCool TC System: Device Premarket Notification ThermaCool TC System (Model TC) K021402, Cleared 11/5/02 ThermaCool TC System (Model TC) KO013639, Cleared 1/29/02 Thbermage ThermnaC… | 2002 |
| * | K013639 | Thermage Thermacool TC SystemSummary page 1…Premarket Notification ThermaCool TC System (Model TC) K021402, Cleared 11/5/02 ThermaCool TC System (Model TC) KO013639, Cleared 1/29/02 Thbermage ThermnaCool HA System KO013034, Cleared 10/4/01 Thermag~e ThermaCo… | 2002 |
| * | K013034 | Modification to: Thermacool IiaSummary page 1…K021402, Cleared 11/5/02 ThermaCool TC System (Model TC) KO013639, Cleared 1/29/02 Thbermage ThermnaCool HA System KO013034, Cleared 10/4/01 Thermag~e ThermaCool HI System K003 183. Cleared 12/8/00 Thermage ThermaCoo… | 2001 |
| * | K003183 | Thermage Thermacool II SystemSummary page 1…KO013639, Cleared 1/29/02 Thbermage ThermnaCool HA System KO013034, Cleared 10/4/01 Thermag~e ThermaCool HI System K003 183. Cleared 12/8/00 Thermage ThermaCool System K000944, Cleared 7/19/00 Other ThermiaC… | 2000 |
| * | K000944 | Thermage Thermacool SystemSummary page 1…KO013034, Cleared 10/4/01 Thermag~e ThermaCool HI System K003 183. Cleared 12/8/00 Thermage ThermaCool System K000944, Cleared 7/19/00 Other ThermiaCool System Accessories that are the subject of this 510(k) include:… | 2000 |
| * | K030142 | Thermacool TC SystemSummary page 1…ect of this 510(k) include: Accessory Predicate Premarket Notification Coupling Fluid ThermaCool Coupling K030 142, Cleared 2/3/03 Fluid TF-2… | 2003 |
What descends from it? (527)
See all 5278 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051214 | Aluma Skin Renewal System | 2005 | 476 |
| K070004 | Accent | 2007 | 181 |
| K043402 | Thermage Thermacool System | 2005 | 124 |
| K051710 | Thermage Thermacool Coupling Fluid | 2005 | 56 |
| K072849 | Modification to Thermage Thermacool System | 2008 | 20 |
| K090580 | Thermage Thermacool NXT System and Accessories | 2009 | 19 |
| K083590 | Iskra Medical Green Irf Prestige | 2009 | 13 |
| K092191 | Exilis, Model 5000 | 2009 | 12 |
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 9 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 3 of the 26 ancestors have a recall of any class.
- Of its descendants, K051214 (Lumenis, Inc., 2005) has gone furthest, with 476 descendants of its own.
- 6 other devices also cite its predicate K021402.
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 Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.
Non-invasive treatment of periorbital wrinkles and rhytids.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033942 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033942: 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/K033942
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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