510(k) Report

510(k) · Cleared

Cleared

Thermacool TC System

K031046510(k) SpecialCleared May 22, 200350-day reviewClass II21 CFR 878.4400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Thermage, Inc. · GEI Electrosurgical, Cutting & Coagulation & Accessories

Cleared on May 22, 2003 as substantially equivalent to K013639 (Thermage, Inc., 2002) and 1 other predicate after a 50-day review. Its family tree reaches back 10 generations to 1995. 22 later devices descend from it.

Decided
May 22, 2003
Review
50 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). 22 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1994: 2 other ancestors1999: 1 other ancestor1996: 5 other ancestors1980: 1 other ancestor1995: 2 other ancestors1992: 2 other ancestors2008: 1 descendant cleared2012: 1 descendant cleared2009: 1 descendant cleared2010: 1 descendant cleared2017: 1 descendant cleared2013: 1 descendant cleared2018: 1 descendant cleared2025: 7 descendants cleared2023: 2 descendants cleared2024: 4 descendants cleared2022: 1 descendant cleared2026: 1 descendant clearedK943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995×2: 2 generations cleared close together, K961069 (1996), K962445 (1996) K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K000944 · Thermage Thermacool System · Thermage, Inc. · 2000×2: 2 generations cleared close together, K013034 (2001), K013639 (2002) K021402 · Thermage Thermacool TC System · Thermage, Inc. · 200219801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 3 other ancestors3 generations back: 2 other ancestors4 generations back: 2 other ancestors5 generations back: 7 other ancestors6 generations back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 4 descendants3 generations forward: 10 descendants4 generations forward: 4 descendants5 generations forward: 1 descendant K021402 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013639 · Thermage Thermacool TC System · Thermage, Inc. · 2002K013034 · Modification to: Thermacool Iia · Thermage, Inc. · 2001K000944 · Thermage Thermacool System · Thermage, Inc. · 2000K981870 · Visage Cosmetic Surgery System · Arthrocare Corp. · 1998K973478 · Arthrocare Sinus Electrosurgery System · Arthrocare Corp. · 1998K964849 · Arthrocare Dermatologic Electrosurgery System · Arthrocare Corp. · 1997K962445 · Arthrocare Dental Electrosurgery System · Arthrocare Corp. · 1996K961069 · Arthrocare Urologic Multi-Electrode Electrosurgery System · Arthrocare Corp. · 1996K943450 · Arthrocare Arthroscopic Electrosurgery System Model 970 · Arthrocare Corp. · 1995−10−50+5
  1. Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 6 generations between
  3. 3 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  4. 2 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  5. 1 generation backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  6. This deviceK031046 Thermacool TC SystemThermage, Inc. · 2003
  7. Descendant · cites it directly · 20 of its ownK072849 Modification to Thermage Thermacool SystemThermage, Inc. · 2008
  8. Descendant · cites it directly · 19 of its ownK090580 Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 2009
  9. Descendant · 2 generations on · 17 of its ownK132431 Thermage CPT SystemSolta Medical, Inc. · 2013 · Recalled
  10. Descendant · 2 generations on · 13 of its ownK170758 Thermage FLX System and AccessoriesSolta Medical · 2017
  11. Descendant · 3 generations on · 2 of its ownK230663 DensityJeisys Medical, Inc. · 2023
Show all 10 generations
  1. Root · 10 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 9 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 8 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 7 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 6 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 5 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 4 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 3 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 2 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 1 generation backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. This deviceK031046 Thermacool TC SystemThermage, Inc. · 2003

Showing 5 of 22 descendants. See all descendants

Descendants cleared per year

2008: 12009: 12010: 12012: 12013: 12017: 12018: 12022: 12023: 22024: 42025: 72026: 1
2008high 7 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 22 · See all
  • K072849Modification to Thermage Thermacool SystemThermage, Inc. · 2008 · cites it directly20descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−9K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−8K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−7K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−6K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−5K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−4K000944Thermage Thermacool SystemThermage, Inc.2000—
−3K013034Modification to: Thermacool IiaThermage, Inc.2001—
−2K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−1K021402Thermage Thermacool TC SystemThermage, Inc.2002—
0 (this device)K031046Thermacool TC SystemThermage, Inc.2003—
+1K072849Modification to Thermage Thermacool SystemThermage, Inc.2008—
+1K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.2009—
+2K132431Thermage CPT SystemSolta Medical, Inc.20131
+2K170758Thermage FLX System and AccessoriesSolta Medical2017—
+3K230663DensityJeisys Medical, Inc.2023—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198010
199220
199420
199520
199650
199910
200020

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
200910
201010
201210
201310
201710
201810
202210
202320
202440
202570
202610
FIG. 1 — Lineage of K031046, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K013639Thermage Thermacool TC SystemThermage, Inc.2002—
*K021402Thermage Thermacool TC System
Summary page 1
…ProCode: 79GEI Equivalent Device(s): The modified TliermaCool TC System claims substantial equivalence to the ThermaCooZ Tc System KO13639 and K021402. Description of the Device: The device as described in the above referenced Premarket Notifications has been modified…
Thermage, Inc.2002—

Also cleared against K013639: 10 other devices →

What descends from it? (22)

See all 22

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K072849Modification to Thermage Thermacool SystemThermage, Inc.200820
K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919
K120527Alpha Orthopaedics AT2 SystemAlpha Orthopaedics, Inc.20120

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, K072849 (Thermage, Inc., 2008) has gone furthest, with 20 descendants of its own.
  • 10 other devices also cite its predicate K013639.

How does its category compare?

All GEI devices

GEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GEI

52in 2025

2007: 502008: 612009: 422010: 462011: 352012: 392013: 482014: 492015: 472016: 642017: 522018: 472019: 482020: 592021: 462022: 552023: 652024: 592025: 522026 (partial year): 43
2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007: 51 days median2008: 71 days median2009: 130 days median2010: 109 days median2011: 135 days median2012: 133 days median2013: 136 days median2014: 103 days median2015: 123 days median2016: 108 days median2017: 72 days median2018: 93 days median2019: 93 days median2020: 105 days median2021: 146 days median2022: 150 days median2023: 104 days median2024: 125 days median2025: 113 days median2026 (partial year): 183 days median
2007high 183 (2026) · low 51 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GEI

4in 2025

2007: 212008: 192009: 272010: 512011: 322012: 302013: 132014: 32015: 42016: 32017: 22018: 62019: 52020: 12021: 62022: 492023: 27, 4 Class I2024: 22, 10 Class I2025: 42026 (partial year): 8
2007high 51 (2010) · low 1 (2020)2026

Class I (14 since 2007) Class II/III not classified

Adverse event reports per year · GEI

7,592in 2025

2007: 2,7952008: 2,5562009: 3,5912010: 3,3772011: 4,4632012: 5,2162013: 4,8972014: 4,9082015: 4,9362016: 5,6162017: 6,0732018: 6,5452019: 7,0672020: 6,4902021: 6,3542022: 6,1032023: 7,1762024: 7,8972025: 7,592
2007high 7,897 (2024) · low 2,556 (2008)2025

MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20075051212,795
20086171192,556
200942130273,591
201046109513,377
201135135324,463
201239133305,216
201348136134,897
20144910334,908
20154712344,936
20166410835,616
2017527226,073
2018479366,545
2019489357,067
20205910516,490
20214614666,354
202255150496,103
20236510427 (4)7,176
20245912522 (10)7,897
20255211347,592
2026431838—

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.

Also cleared against K013639

10 other devices cite the same predicate.

  • K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics · 2010
  • K082956Alpha Orthopaedics AT2 SystemAlpha Orthopaedics · 2008
  • K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc. · 2008
  • K060948Portrait PSR3Rhytec Incorporated · 20061 recall
  • K043402Thermage Thermacool SystemThermage, Inc. · 2005
  • K033942Thermage Thermacool SystemThermage, Inc. · 2004

More from Thermage, Inc.

18 FDA decisions under this applicant name. See the company

  • K101490Fraxel RE:Store Dual Laser System: Model, MC-Sys-SR1500-D-USThermage, Inc. · 20102 recalls
  • K072849Modification to Thermage Thermacool SystemThermage, Inc. · 2008
  • K052936Thermage Thermacool SystemThermage, Inc. · 2007
  • K061001ThermassageThermage, Inc. · 2006
  • K053365Modification to Thermage Thermacool SystemThermage, Inc. · 2005

Recent decisions in GEI

The GEI category page

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  • K254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLC · 2026
  • K261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLC · 2026
  • K254185Potenza PrimeJeisys Medical Incorporated · 2026

https://510kreport.com/device/K031046 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031046: 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/K031046

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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