510(k) · Cleared
ClearedModification to Thermage 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 18, 2008 as substantially equivalent to K033942 (Thermage, Inc., 2004) and 4 other predicates after a 106-day review. Its family tree reaches back 13 generations to 1995. 20 later devices descend from it.
- Decided
- Jan 18, 2008
- Review
- 106 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 13 generations to K943450 (1995). 31 ancestors in all, the oldest K800617 (1980). 20 later devices descend from it, 2 citing it directly.
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 9 generations between
- 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 2 generations backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- 1 generation backK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
- This deviceK072849 Modification to Thermage Thermacool SystemThermage, Inc. · 2008
- Descendant · cites it directly · 19 of its ownK090580 Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 2009
- Descendant · 2 generations on · 17 of its ownK132431 Thermage CPT SystemSolta Medical, Inc. · 2013 · Recalled
- Descendant · 2 generations on · 13 of its ownK170758 Thermage FLX System and AccessoriesSolta Medical · 2017
- Descendant · 3 generations on · 2 of its ownK230663 DensityJeisys Medical, Inc. · 2023
- Descendant · 3 generations on · 2 of its ownK221989 The OligioWontech Co., Ltd. · 2022
Show all 13 generations
- Root · 13 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 12 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 10 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 9 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 8 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 7 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 6 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 5 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 3 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 2 generations backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- 1 generation backK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
- This deviceK072849 Modification to Thermage Thermacool SystemThermage, Inc. · 2008
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 2009 · cites it directly19descendants
- K132431Thermage CPT SystemSolta Medical, Inc. · 2013 · 2 generations on17descendants
- K170758Thermage FLX System and AccessoriesSolta Medical · 2017 · 2 generations on13descendants
- K230663DensityJeisys Medical, Inc. · 2023 · 3 generations on2descendants
- K221989The OligioWontech Co., Ltd. · 2022 · 3 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −12 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −10 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −9 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −8 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −7 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −6 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −5 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −3 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −2 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| −1 | K051710 | Thermage Thermacool Coupling Fluid | Thermage, Inc. | 2005 | — |
| 0 (this device) | K072849 | Modification to Thermage Thermacool System | Thermage, Inc. | 2008 | — |
| +1 | K090580 | Thermage Thermacool NXT System and Accessories | Solta Medical, Inc. | 2009 | — |
| +2 | K132431 | Thermage CPT System | Solta Medical, Inc. | 2013 | 1 |
| +2 | K170758 | Thermage FLX System and Accessories | Solta Medical | 2017 | — |
| +3 | K230663 | Density | Jeisys Medical, Inc. | 2023 | — |
| +3 | K221989 | The Oligio | Wontech Co., Ltd. | 2022 | — |
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 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K033942 | Thermage Thermacool SystemSummary page 1…Predicate Device Predicate Devices Premarket Notification Number K033942 Components and accessories K032088… | 2004 |
| * | K032088 | Modification to Thermacool TC SystemSummary page 1…Premarket Notification Number K033942 Components and accessories K032088 K031046 compatible with the ThermaCool… | 2003 |
| * | K031046 | Thermacool TC SystemSummary page 1…K033942 Components and accessories K032088 K031046 compatible with the ThermaCool K0346 System (Model NXT)… | 2003 |
| Kept off the family tree | K030346 | FDA’s K030346 is Twinheads TH-101 Extracorporeal Shock Wave Lithotripter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2003 |
| Kept off the family tree | K040340 | FDA’s K040340 is K-Y Brand Warming Ultragel Personal Lubricant Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2004 |
| * | K051710 | Thermage Thermacool Coupling Fluid | 2005 |
| * | K052778 | Thermage Thermacool Skin MarketingSummary page 1…K04340 K05171l0 K052778 C. Device Description The Multiplex Assembly is a 4-electode design incorporating four 3.00-Cni 2… | 2005 |
What descends from it? (20)
See all 202 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 13 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- 3 of the 31 ancestors have a recall of any class.
- Of its descendants, K090580 (Solta Medical, Inc., 2009) has gone furthest, with 19 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. 2008, 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 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 including upper and lower
eyelids
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/K072849 · printed Nov 4, 2026
Cite this page
510(k) Report. “K072849: Modification to Thermage Thermacool System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K072849
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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