510(k) · Cleared

Cleared

Thermage Thermacool II System

K003183510(k) TraditionalCleared Dec 8, 200058-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 Dec 8, 2000 after a 58-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 833 later devices descend from it.

Decided: Dec 8, 2000
Review: 58 days
Class: Class II
Product code: GEI
Recalls: None
Predicates: 0

833 later devices descend from it, 6 citing it directly.

This deviceK003183 Thermage Thermacool II SystemThermage, Inc. · 2000
Descendant · cites it directly · 800 of its ownK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
Descendant · cites it directly · 799 of its ownK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
Descendant · cites it directly · 789 of its ownK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
Descendant · 2 generations on · 773 of its ownK030142 Thermacool TC SystemThermage, Inc. · 2003
Descendant · 3 generations on · 678 of its ownK031671 Polaris WRSyneron Medical, Ltd. · 2003

Showing 5 of 833 descendants. See all descendants

Descendants cleared per year

2001high 91 (2025) · low 1 (2001)2026

Most influential descendants

Showing 5 of 833 · See all

K013034Modification to: Thermacool IiaThermage, Inc. · 2001 · cites it directly800descendants
K013639Thermage Thermacool TC SystemThermage, Inc. · 2002 · cites it directly799descendants
K021402Thermage Thermacool TC SystemThermage, Inc. · 2002 · cites it directly789descendants
K030142Thermacool TC SystemThermage, Inc. · 2003 · 2 generations on773descendants
K031671Polaris WRSyneron Medical, Ltd. · 2003 · 3 generations on678descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003183	Thermage Thermacool II System	Thermage, Inc.	2000	—
+1	K013034	Modification to: Thermacool Iia	Thermage, Inc.	2001	—
+1	K013639	Thermage Thermacool TC System	Thermage, Inc.	2002	—
+1	K021402	Thermage Thermacool TC System	Thermage, Inc.	2002	—
+2	K030142	Thermacool TC System	Thermage, Inc.	2003	—
+3	K031671	Polaris WR	Syneron Medical, Ltd.	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0
2002	2	0
2003	5	0
2004	3	0
2005	5	0
2006	6	0
2007	14	0
2008	25	0
2009	22	0
2010	21	0
2011	15	0
2012	20	0
2013	30	0
2014	31	0
2015	32	0
2016	48	0
2017	44	0
2018	38	0
2019	31	0
2020	48	0
2021	47	0
2022	62	0
2023	54	0
2024	82	0
2025	91	0
2026	56	0

FIG. 1 — Lineage of K003183, 2000–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (833)

See all 833

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

Number	Device	Applicant	Decided	Descendants
K013034	Modification to: Thermacool Iia	Thermage, Inc.	2001	800
K013639	Thermage Thermacool TC System	Thermage, Inc.	2002	799
K021402	Thermage Thermacool TC System	Thermage, Inc.	2002	789
K033942	Thermage Thermacool System	Thermage, Inc.	2004	527
K043402	Thermage Thermacool System	Thermage, Inc.	2005	124
K072261	Finesse System	Primaeva Medical, Inc.	2007	100

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, K013034 (Thermage, Inc., 2001) has gone furthest, with 800 descendants of its own.

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

2007high 65 (2023) · low 35 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GEI

113in 2025

2007high 183 (2026) · low 51 (2007)2026

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

Recalls per year · GEI

4in 2025

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

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

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	—

https://510kreport.com/device/K003183 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003183: Thermage Thermacool II System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K003183

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026