510(k) Report

510(k) · Cleared

Cleared

Thermage Thermacool TC System

K021402510(k) TraditionalCleared Nov 5, 2002187-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 Nov 5, 2002 as substantially equivalent to K000944 (Thermage, Inc., 2000) and 5 other predicates after a 187-day review. Its family tree reaches back 9 generations to 1995. 789 later devices descend from it.

Decided
Nov 5, 2002
Review
187 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
6

Its longest line of descent runs back 9 generations to K943450 (1995). 24 ancestors in all, the oldest K800617 (1980). 789 later devices descend from it, 7 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 ancestors2004: 3 descendants cleared2003: 4 descendants cleared2006: 6 descendants cleared2005: 5 descendants cleared2008: 23 descendants cleared2012: 19 descendants cleared2009: 20 descendants cleared2007: 13 descendants cleared2010: 21 descendants cleared2020: 44 descendants cleared2013: 28 descendants cleared2014: 31 descendants cleared2011: 15 descendants cleared2015: 32 descendants cleared2017: 42 descendants cleared2018: 35 descendants cleared2023: 51 descendants cleared2022: 59 descendants cleared2019: 29 descendants cleared2016: 45 descendants cleared2025: 90 descendants cleared2021: 41 descendants cleared2024: 78 descendants cleared2026: 55 descendants 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) 19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors2 generations back: 2 other ancestors3 generations back: 2 other ancestors4 generations back: 7 other ancestors5 generations back: 1 other ancestor 1 generation forward: 7 descendants2 generations forward: 15 descendants3 generations forward: 38 descendants4 generations forward: 72 descendants5 generations forward: 97 descendants6 generations forward: 112 descendants7 generations forward: 132 descendants8 generations forward: 125 descendants9 generations forward: 98 descendants10 generations forward: 54 descendants11 generations forward: 26 descendants12 generations forward: 4 descendants13 generations forward: 2 descendants14 generations forward: 1 descendant15 generations forward: 5 descendants16 generations forward: 1 descendant K013639 · 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. · 1995−50+5+10+15
  1. Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 5 generations between
  3. 3 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  4. 2 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  5. 1 generation backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  6. This deviceK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  7. Descendant · cites it directly · 773 of its ownK030142 Thermacool TC SystemThermage, Inc. · 2003
  8. Descendant · 2 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003
  9. Descendant · cites it directly · 527 of its ownK033942 Thermage Thermacool SystemThermage, Inc. · 2004
  10. Descendant · cites it directly · 496 of its ownK040135 Thermage Thermacool SystemThermage, Inc. · 2004
  11. Descendant · 2 generations on · 476 of its ownK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
Show all 9 generations
  1. Root · 9 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 8 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 7 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 6 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 5 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 4 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 3 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 2 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 1 generation backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. This deviceK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002

Showing 5 of 789 descendants. See all descendants

Descendants cleared per year

2003: 42004: 32005: 52006: 62007: 132008: 232009: 202010: 212011: 152012: 192013: 282014: 312015: 322016: 452017: 422018: 352019: 292020: 442021: 412022: 592023: 512024: 782025: 902026: 55
2003high 90 (2025) · low 3 (2004)2026

Most influential descendants

Showing 5 of 789 · See all
  • K030142Thermacool TC SystemThermage, Inc. · 2003 · cites it directly773descendants
  • K031671Polaris WRSyneron Medical, Ltd. · 2003 · 2 generations on678descendants
  • K033942Thermage Thermacool SystemThermage, Inc. · 2004 · cites it directly527descendants
  • K040135Thermage Thermacool SystemThermage, Inc. · 2004 · cites it directly496descendants
  • K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005 · 2 generations on476descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−9K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−8K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−7K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−6K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−5K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−4K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−3K000944Thermage Thermacool SystemThermage, Inc.2000—
−2K013034Modification to: Thermacool IiaThermage, Inc.2001—
−1K013639Thermage Thermacool TC SystemThermage, Inc.2002—
0 (this device)K021402Thermage Thermacool TC SystemThermage, Inc.2002—
+1K030142Thermacool TC SystemThermage, Inc.2003—
+2K031671Polaris WRSyneron Medical, Ltd.2003—
+1K033942Thermage Thermacool SystemThermage, Inc.2004—
+1K040135Thermage Thermacool SystemThermage, Inc.2004—
+2K051214Aluma Skin Renewal SystemLumenis, Inc.2005—

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
200340
200430
200550
200660
2007130
2008230
2009200
2010210
2011150
2012190
2013280
2014310
2015320
2016450
2017420
2018350
2019290
2020440
2021410
2022590
2023510
2024780
2025900
2026550
FIG. 1 — Lineage of K021402, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K000944Thermage Thermacool SystemThermage, Inc.2000—
*K003183Thermage Thermacool II SystemThermage, Inc.2000—
*K013034Modification to: Thermacool IiaThermage, Inc.2001—
*K013639Thermage Thermacool TC SystemThermage, Inc.2002—
*K000079Nikopad Electrosurgical Grounding Pad, Model 4777M
Summary page 1
…skin marking paper): 1 Accessory I Predicate I PremarketNotification R-Pad Nilcorned E1ectrosurgical K000079, Cleared 2/4/00 GroundingPad Coupling Fluid Cadwell Lectron II K9338…
Nikomed U.S.A., Inc.20002
*K933804Lectron II Conductive Gel/Cadwell Electrode Gel
Summary page 1
…Nilcorned E1ectrosurgical K000079, Cleared 2/4/00 GroundingPad Coupling Fluid Cadwell Lectron II K933804, Cleared 3/22/94 'kh Marking Skin Mu& Class I, Exempt (878.4660) Paper…
Cadwell Laboratories, Inc.1994—
*—Skin Marking Paper
Named without a submission number
—

Also cleared against K000944: 9 other devices →

What descends from it? (789)

See all 789

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

NumberDeviceApplicantDecidedDescendants
K030142Thermacool TC SystemThermage, Inc.2003773
K033942Thermage Thermacool SystemThermage, Inc.2004527
K040135Thermage Thermacool SystemThermage, Inc.2004496
K032088Modification to Thermacool TC SystemThermage, Inc.2003131
K043402Thermage Thermacool SystemThermage, Inc.2005124
K060948Portrait PSR3Rhytec Incorporated2006110
K031046Thermacool TC SystemThermage, Inc.200322

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 7 years and passes through 2 companies; a new generation was cleared every 9 months on median.
  • 3 of the 24 ancestors have a recall of any class.
  • Of its descendants, K030142 (Thermage, Inc., 2003) has gone furthest, with 773 descendants of its own.
  • 9 other devices also cite its predicate K000944.

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 Thermage ThermaCool TC System (Model TC) is indicated for use in:

Dermatologic and general surgical procedures for electrocoagulation and hemostasis,

Non-invasive treatment of periorbital wrinkles and rhytids

Indications for use as stated in the FDA summary.

Also cleared against K000944

9 other devices cite the same predicate.

  • K130689Symphony RF GeneratorThermigen, Inc. · 2013
  • K082962Tivamed Cooled RF System, Model 78001Tivamed, Inc. · 2008
  • K072261Finesse SystemPrimaeva Medical, Inc. · 2007
  • K043402Thermage Thermacool SystemThermage, Inc. · 2005
  • K033942Thermage Thermacool SystemThermage, Inc. · 2004
  • K022266Aurora SRSyneron Medical, Ltd. · 2002

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

  • K262386SafeAir Electrosurgical Generator with Smoke Evacuation (0795-001-000);SafeAir Generator 3-Pedal Footswitch…Stryker Instruments · 2026
  • K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch…Stryker Instruments · 2026
  • 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/K021402 · printed Nov 6, 2026

Cite this page

510(k) Report. “K021402: Thermage 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/K021402

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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