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 Jul 19, 2000 as substantially equivalent to K984552 (Radionics, Inc., 1999) and 2 other predicates after a 118-day review. Its family tree reaches back 6 generations to 1995. 1,069 later devices descend from it.
- Decided
- Jul 19, 2000
- Review
- 118 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K943450 (1995). 18 ancestors in all, the oldest K800617 (1980). 1,069 later devices descend from it, 10 citing it directly.
- Root · 6 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 5 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 4 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 3 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 2 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 1 generation backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- This deviceK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- Descendant · cites it directly · 800 of its ownK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- Descendant · cites it directly · 799 of its ownK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- Descendant · cites it directly · 789 of its ownK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- Descendant · 2 generations on · 773 of its ownK030142 Thermacool TC SystemThermage, Inc. · 2003
- Descendant · cites it directly · 750 of its ownK021149 Aurora DSSyneron Medical, Ltd. · 2002
Showing 5 of 1,069 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 1,069 · See all- K013034Modification to: Thermacool IiaThermage, Inc. · 2001 · cites it directly800descendants
- K013639Thermage Thermacool TC SystemThermage, Inc. · 2002 · cites it directly799descendants
- K021402Thermage Thermacool TC SystemThermage, Inc. · 2002 · cites it directly789descendants
- K030142Thermacool TC SystemThermage, Inc. · 2003 · 2 generations on773descendants
- K021149Aurora DSSyneron Medical, Ltd. · 2002 · cites it directly750descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −5 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −4 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −3 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −2 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −1 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| 0 (this device) | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| +1 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| +1 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| +1 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| +2 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| +1 | K021149 | Aurora DS | Syneron Medical, Ltd. | 2002 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 5 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 12 | 0 |
| 2004 | 5 | 0 |
| 2005 | 15 | 0 |
| 2006 | 8 | 0 |
| 2007 | 15 | 0 |
| 2008 | 30 | 0 |
| 2009 | 25 | 0 |
| 2010 | 27 | 0 |
| 2011 | 18 | 0 |
| 2012 | 22 | 0 |
| 2013 | 35 | 0 |
| 2014 | 37 | 0 |
| 2015 | 43 | 0 |
| 2016 | 56 | 0 |
| 2017 | 60 | 0 |
| 2018 | 49 | 0 |
| 2019 | 40 | 0 |
| 2020 | 54 | 0 |
| 2021 | 60 | 0 |
| 2022 | 80 | 0 |
| 2023 | 72 | 0 |
| 2024 | 97 | 0 |
| 2025 | 128 | 0 |
| 2026 | 76 | 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? (3)
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 |
|---|---|---|---|
| * | K984552 | Cool-Tip RF SystemSummary page 1…me: Device, Electrosurgical Cutting and Coagulation and Accessories (21 CFR 878.4400) Predicate Devices - Device Premarket Notification Radionics Cool-Tip RF System - - K984552, 03/05/99 ArthroCare Visage Cosmetic Surgery System K981870, 08/20/98 Candela Dynamic Cooling Device K981033, 08/15/96 Device Des… | 1999 |
| * | K981870 | Visage Cosmetic Surgery SystemSummary page 1…ssories (21 CFR 878.4400) Predicate Devices - Device Premarket Notification Radionics Cool-Tip RF System - - K984552, 03/05/99 ArthroCare Visage Cosmetic Surgery System K981870, 08/20/98 Candela Dynamic Cooling Device K981033, 08/15/96 Device Description: The Thermage ThermaCool System consists of the fo… | 1998 |
| * | K951033 | Andela Dynamic Cooling Device Our OCR of the scanned summary read K981033, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Candela Dynamic Cooling Device”. | 1996 |
What descends from it? (1,069)
See all 1,06910 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K013034 | Modification to: Thermacool Iia | 2001 | 800 |
| K013639 | Thermage Thermacool TC System | 2002 | 799 |
| K021402 | Thermage Thermacool TC System | 2002 | 789 |
| K021149 | Aurora DS | 2002 | 750 |
| K022266 | Aurora SR | 2002 | 705 |
| K033942 | Thermage Thermacool System | 2004 | 527 |
| K043402 | Thermage Thermacool System | 2005 | 124 |
| K072261 | Finesse System | 2007 | 100 |
| K130689 | Symphony RF Generator | 2013 | 11 |
| K082962 | Tivamed Cooled RF System, Model 78001 | 2008 | 7 |
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 5 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 2 of the 18 ancestors have a recall of any class.
- Of its descendants, K013034 (Thermage, Inc., 2001) has gone furthest, with 800 descendants of its own.
- 11 other devices also cite its predicate K984552.
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K000944 · printed Nov 6, 2026
Cite this page
510(k) Report. “K000944: 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/K000944
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026