510(k) Report

510(k) · Cleared

Cleared

Thermage Thermacool Coupling Fluid

K051710510(k) TraditionalCleared Jul 19, 200522-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 Jul 19, 2005 as substantially equivalent to K033942 (Thermage, Inc., 2004) after a 22-day review. Its family tree reaches back 12 generations to 1995. 56 later devices descend from it.

Decided
Jul 19, 2005
Review
22 days
Class
Class II
Product code
GEI
Recalls
None
Predicates
1

Its longest line of descent runs back 12 generations to K943450 (1995). 27 ancestors in all, the oldest K800617 (1980). 56 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2000: 2 other ancestors1999: 1 other ancestor1996: 5 other ancestors1994: 2 other ancestors1980: 1 other ancestor1995: 2 other ancestors1992: 2 other ancestors2008: 2 descendants cleared2007: 1 descendant cleared2010: 1 descendant cleared2009: 2 descendants cleared2017: 5 descendants cleared2013: 1 descendant cleared2018: 2 descendants cleared2025: 8 descendants cleared2023: 5 descendants cleared2024: 7 descendants cleared2022: 5 descendants cleared2012: 1 descendant cleared2026: 1 descendant cleared2015: 4 descendants cleared2014: 1 descendant cleared2016: 3 descendants cleared2019: 3 descendants cleared2020: 2 descendants cleared2021: 2 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) ×2: 2 generations cleared close together, K021402 (2002), K030142 (2003) K033942 · Thermage Thermacool System · Thermage, Inc. · 200419801990200020102020
Other ancestors, by generationDescendants, by generation 2 generations back: 1 other ancestor3 generations back: 4 other ancestors4 generations back: 2 other ancestors5 generations back: 7 other ancestors6 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 4 descendants3 generations forward: 11 descendants4 generations forward: 5 descendants5 generations forward: 4 descendants6 generations forward: 4 descendants7 generations forward: 5 descendants8 generations forward: 10 descendants9 generations forward: 6 descendants10 generations forward: 3 descendants K033942 · Thermage Thermacool System · Thermage, Inc. · 2004K030142 · Thermacool TC System · Thermage, Inc. · 2003K021402 · 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+10
  1. Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 8 generations between
  3. 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  4. 2 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  5. 1 generation backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
  6. This deviceK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
  7. Descendant · cites it directly · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
  8. Descendant · 2 generations on · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
  9. Descendant · 3 generations on · 32 of its ownK090094 Zeltiq SystemZeltiq Aesthetics · 2009
  10. Descendant · 4 generations on · 31 of its ownK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
  11. Descendant · 5 generations on · 30 of its ownK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
Show all 12 generations
  1. Root · 12 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
  2. 11 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
  3. 10 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
  4. 9 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
  5. 8 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
  6. 7 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
  7. 6 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
  8. 5 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
  9. 4 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
  10. 3 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
  11. 2 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
  12. 1 generation backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
  13. This deviceK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005

Showing 5 of 56 descendants. See all descendants

Descendants cleared per year

2007: 12008: 22009: 22010: 12012: 12013: 12014: 12015: 42016: 32017: 52018: 22019: 32020: 22021: 22022: 52023: 52024: 72025: 82026: 1
2007high 8 (2025) · low 0 (2011)2026

Most influential descendants

Showing 5 of 56 · See all
  • K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007 · cites it directly34descendants
  • K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008 · 2 generations on33descendants
  • K090094Zeltiq SystemZeltiq Aesthetics · 2009 · 3 generations on32descendants
  • K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012 · 4 generations on31descendants
  • K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014 · 5 generations on30descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−12K943450Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp.1995—
−11K961069Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp.1996—
−10K962445Arthrocare Dental Electrosurgery SystemArthrocare Corp.1996—
−9K964849Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp.1997—
−8K973478Arthrocare Sinus Electrosurgery SystemArthrocare Corp.1998—
−7K981870Visage Cosmetic Surgery SystemArthrocare Corp.1998—
−6K000944Thermage Thermacool SystemThermage, Inc.2000—
−5K013034Modification to: Thermacool IiaThermage, Inc.2001—
−4K013639Thermage Thermacool TC SystemThermage, Inc.2002—
−3K021402Thermage Thermacool TC SystemThermage, Inc.2002—
−2K030142Thermacool TC SystemThermage, Inc.2003—
−1K033942Thermage Thermacool SystemThermage, Inc.2004—
0 (this device)K051710Thermage Thermacool Coupling FluidThermage, Inc.2005—
+1K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.2007—
+2K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics2008—
+3K090094Zeltiq SystemZeltiq Aesthetics2009—
+4K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc.2012—
+5K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc.2014—

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
200710
200820
200920
201010
201210
201310
201410
201540
201630
201750
201820
201930
202020
202120
202250
202350
202470
202580
202610
FIG. 1 — Lineage of K051710, 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? (1)

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
*K033942Thermage Thermacool System
Summary page 1
…s: Accessory Predicate ] Premarket Notification Coupling Fluid ThernmaCool Couplin Fluid TF-2 K033942, Cleared 2/4/04 C. Device Description The Thermage ThermaCool System consists of the following compon…
Thermage, Inc.2004—

Also cleared against K033942: 7 other devices →

What descends from it? (56)

See all 56

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

NumberDeviceApplicantDecidedDescendants
K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc.200734
K072849Modification to Thermage Thermacool SystemThermage, Inc.200820
K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc.200919
K094041Alpha Orthopaedics AT3 SystemAlpha Orthopaedics20100

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 10 years and passes through 2 companies; a new generation was cleared every 9 months on median.
  • 3 of the 27 ancestors have a recall of any class.
  • Of its descendants, K072152 (Juniper Medical, Inc., 2007) has gone furthest, with 34 descendants of its own.
  • 7 other devices also cite its predicate K033942.

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 System is indicated for use in:

* Dermatologic and general surgical procedures for electro coagulation and hemostasis,

* Non-invasive treatment of periorbital wrinkles and rhytids

* Non-invasive treatment of facial wrinkles and rhytids

Indications for use as stated in the FDA summary.

Also cleared against K033942

7 other devices cite the same predicate.

  • K092191Exilis, Model 5000Btl Industries, Ltd. · 2009
  • K090580Thermage Thermacool NXT System and AccessoriesSolta Medical, Inc. · 2009
  • K083590Iskra Medical Green Irf PrestigeIskra Medical, D.O.O. · 2009
  • K072849Modification to Thermage Thermacool SystemThermage, Inc. · 2008
  • K070004AccentAlma Lasers, Ltd. · 2007
  • K051214Aluma Skin Renewal SystemLumenis, Inc. · 2005

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/K051710 · printed Nov 6, 2026

Cite this page

510(k) Report. “K051710: Thermage Thermacool Coupling Fluid.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051710

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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