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 Dec 13, 2005 after an 11-day review. The FDA summary names no predicate by number. 203 later devices descend from it.
- Decided
- Dec 13, 2005
- Review
- 11 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 0
203 later devices descend from it, 6 citing it directly.
- This deviceK053365 Modification to Thermage Thermacool SystemThermage, Inc. · 2005
- Descendant · cites it directly · 181 of its ownK070004 AccentAlma Lasers, Ltd. · 2007
- Descendant · cites it directly · 110 of its ownK060948 Portrait PSR3Rhytec Incorporated · 2006 · Recalled
- Descendant · 2 generations on · 109 of its ownK071786 Portrait PSRRhytec Incorporated · 2007
- Descendant · 3 generations on · 104 of its ownK072394 Portrait Stand-OffRhytec Incorporated · 2007
- Descendant · 4 generations on · 102 of its ownK073572 Matrix RF ApplicatorSyneron Medical, Ltd. · 2008
Showing 5 of 203 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 203 · See all- K070004AccentAlma Lasers, Ltd. · 2007 · cites it directly181descendants
- K060948Portrait PSR3Rhytec Incorporated · 2006 · cites it directly110descendants
- K071786Portrait PSRRhytec Incorporated · 2007 · 2 generations on109descendants
- K072394Portrait Stand-OffRhytec Incorporated · 2007 · 3 generations on104descendants
- K073572Matrix RF ApplicatorSyneron Medical, Ltd. · 2008 · 4 generations on102descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K053365 | Modification to Thermage Thermacool System | Thermage, Inc. | 2005 | — |
| +1 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| +1 | K060948 | Portrait PSR3 | Rhytec Incorporated | 2006 | 1 |
| +2 | K071786 | Portrait PSR | Rhytec Incorporated | 2007 | — |
| +3 | K072394 | Portrait Stand-Off | Rhytec Incorporated | 2007 | — |
| +4 | K073572 | Matrix RF Applicator | Syneron Medical, Ltd. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 3 | 0 |
| 2009 | 6 | 0 |
| 2010 | 5 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 9 | 0 |
| 2014 | 7 | 0 |
| 2015 | 4 | 0 |
| 2016 | 9 | 0 |
| 2017 | 9 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 12 | 0 |
| 2022 | 18 | 0 |
| 2023 | 17 | 0 |
| 2024 | 26 | 0 |
| 2025 | 24 | 0 |
| 2026 | 15 | 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?
The FDA summary names no predicate by number.
What descends from it? (203)
See all 2036 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?
- Of its descendants, K070004 (Alma Lasers, Ltd., 2007) has gone furthest, with 181 descendants of its own.
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 electro coagulation and hemostasis
Non-invasive treatment of wrinkles and rhytids
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053365 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053365: 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/K053365
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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