510(k) · Cleared
ClearedThermacool TC 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 3, 2003 as substantially equivalent to K013639 (Thermage, Inc., 2002) and 1 other predicate after a 19-day review. Its family tree reaches back 10 generations to 1995. 773 later devices descend from it.
- Decided
- Feb 3, 2003
- Review
- 19 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K943450 (1995). 25 ancestors in all, the oldest K800617 (1980). 773 later devices descend from it, 3 citing it directly.
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 6 generations between
- 3 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 2 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 1 generation backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- This deviceK030142 Thermacool TC SystemThermage, Inc. · 2003
- Descendant · cites it directly · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
- Descendant · cites it directly · 527 of its ownK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- Descendant · 2 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- Descendant · 2 generations on · 301 of its ownK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- Descendant · 3 generations on · 299 of its ownK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
Show all 10 generations
- Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 6 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 5 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 4 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 3 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 2 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 1 generation backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- This deviceK030142 Thermacool TC SystemThermage, Inc. · 2003
Showing 5 of 773 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 773 · See all- K031671Polaris WRSyneron Medical, Ltd. · 2003 · cites it directly678descendants
- K033942Thermage Thermacool SystemThermage, Inc. · 2004 · cites it directly527descendants
- K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 2 generations on476descendants
- K041959Polaris DS/CometSyneron Medical, Ltd. · 2004 · 2 generations on301descendants
- K053540Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories That Are…Intermedic Arfran, SA · 2006 · 3 generations on299descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −9 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −8 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −7 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −6 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −5 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −4 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −3 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −2 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −1 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| 0 (this device) | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| +1 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| +1 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| +2 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| +2 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| +3 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
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 |
|---|---|---|
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 11 | 0 |
| 2008 | 21 | 0 |
| 2009 | 19 | 0 |
| 2010 | 21 | 0 |
| 2011 | 15 | 0 |
| 2012 | 19 | 0 |
| 2013 | 26 | 0 |
| 2014 | 31 | 0 |
| 2015 | 31 | 0 |
| 2016 | 45 | 0 |
| 2017 | 42 | 0 |
| 2018 | 35 | 0 |
| 2019 | 29 | 0 |
| 2020 | 44 | 0 |
| 2021 | 41 | 0 |
| 2022 | 58 | 0 |
| 2023 | 50 | 0 |
| 2024 | 78 | 0 |
| 2025 | 90 | 0 |
| 2026 | 55 | 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 |
|---|---|---|---|
| * | K013639 | Thermage Thermacool TC System | 2002 |
| * | K021402 | Thermage Thermacool TC SystemSummary page 1…e: 79GEI Equivalent Device(s): The modified ThermaCool TC System accessory claims substantial equivalence to the ThermaCool Z'C System KO13639 and K021402. Description of the Device: The device as described in the above referenced Prernarket Notifications has been modif… | 2002 |
What descends from it? (773)
See all 7733 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 8 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 3 of the 25 ancestors have a recall of any class.
- Of its descendants, K031671 (Syneron Medical, Ltd., 2003) has gone furthest, with 678 descendants of its own.
- 10 other devices also cite its predicate K013639.
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 ThermaCool TC System is indicated for use in
Non-invasive treatment of periorbital rhytids and wrinkles
Dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K030142 · printed Nov 6, 2026
Cite this page
510(k) Report. “K030142: Thermacool TC System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030142
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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