510(k) · Cleared
ClearedImagine TC Skin Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Endymion Medical, Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jul 24, 2009 as substantially equivalent to K051214 (Lumenis, Inc., 2005) and 3 other predicates after a 245-day review. Its family tree reaches back 14 generations to 1995. 101 later devices descend from it.
- Decided
- Jul 24, 2009
- Review
- 245 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 14 generations to K943450 (1995). 87 ancestors in all, the oldest K800617 (1980). 101 later devices descend from it, 12 citing it directly.
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 10 generations between
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 1 generation backK070004 AccentAlma Lasers, Ltd. · 2007
- This deviceK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- Descendant · cites it directly · 64 of its ownK101510 Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011
- Descendant · cites it directly · 57 of its ownK130501 IntensifEndymed Medical, Ltd. · 2014
- Descendant · 2 generations on · 38 of its ownK180189 InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018
- Descendant · cites it directly · 31 of its ownK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- Descendant · 3 generations on · 20 of its ownK192545 PotenzaJeisys Medical Incorporated · 2020
Show all 14 generations
- Root · 14 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 13 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 11 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 10 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 9 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 8 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 7 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 6 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 4 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 3 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 2 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 1 generation backK070004 AccentAlma Lasers, Ltd. · 2007
- This deviceK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
Showing 5 of 101 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 101 · See all- K101510Fractional Skin Resurfacing (FSR) ApplicatorEndymed Medical, Ltd. · 2011 · cites it directly64descendants
- K130501IntensifEndymed Medical, Ltd. · 2014 · cites it directly57descendants
- K180189InMode System with Fractora3D/3D-90 ApplicatorsInmode MD, Ltd. · 2018 · 2 generations on38descendants
- K100586Venus Freeze SystemVenus Concept, Ltd. · 2010 · cites it directly31descendants
- K192545PotenzaJeisys Medical Incorporated · 2020 · 3 generations on20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −13 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −11 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −10 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −9 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −8 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −7 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −6 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −4 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −3 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −2 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −1 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| 0 (this device) | K083461 | Imagine TC Skin Therapy System | Endymion Medical, Ltd. | 2009 | — |
| +1 | K101510 | Fractional Skin Resurfacing (FSR) Applicator | Endymed Medical, Ltd. | 2011 | — |
| +1 | K130501 | Intensif | Endymed Medical, Ltd. | 2014 | — |
| +2 | K180189 | InMode System with Fractora3D/3D-90 Applicators | Inmode MD, Ltd. | 2018 | — |
| +1 | K100586 | Venus Freeze System | Venus Concept, Ltd. | 2010 | — |
| +3 | K192545 | Potenza | Jeisys Medical Incorporated | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1985 | 1 | 0 |
| 1990 | 1 | 0 |
| 1992 | 3 | 0 |
| 1993 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 4 | 0 |
| 1996 | 10 | 0 |
| 1997 | 13 | 0 |
| 1998 | 6 | 0 |
| 1999 | 4 | 0 |
| 2000 | 8 | 0 |
| 2001 | 5 | 0 |
| 2002 | 8 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 1 | 0 |
| 2014 | 7 | 0 |
| 2016 | 4 | 0 |
| 2017 | 3 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 5 | 0 |
| 2021 | 6 | 0 |
| 2022 | 7 | 0 |
| 2023 | 8 | 0 |
| 2024 | 19 | 0 |
| 2025 | 16 | 0 |
| 2026 | 9 | 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? (4)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K051214 | Aluma Skin Renewal SystemSummary page 2…evce NNo Nme51 Date oflaac Lumenis Aluma K051214 Oct 24 2005 Alma Lasers Accent K070004 Jan 18 2006 Thermage… | 2005 |
| * | K070004 | AccentSummary page 2…Date oflaac Lumenis Aluma K051214 Oct 24 2005 Alma Lasers Accent K070004 Jan 18 2006 Thermage ThermaCool K053365 Aug 30 2001 Syneron… | 2007 |
| * | K053365 | Modification to Thermage Thermacool SystemSummary page 2…K051214 Oct 24 2005 Alma Lasers Accent K070004 Jan 18 2006 Thermage ThermaCool K053365 Aug 30 2001 Syneron Polaris K031671 Apr 07 2006 Performance Standards… | 2005 |
| * | K031671 | Polaris WRSummary page 2…K070004 Jan 18 2006 Thermage ThermaCool K053365 Aug 30 2001 Syneron Polaris K031671 Apr 07 2006 Performance Standards Imagine TC Skin Treatment System complies with ANSI AAMI 60601-… | 2003 |
What descends from it? (101)
See all 10112 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101510 | Fractional Skin Resurfacing (FSR) Applicator | 2011 | 64 |
| K130501 | Intensif | 2014 | 57 |
| K100586 | Venus Freeze System | 2010 | 31 |
| K111026 | Apollo | 2011 | 14 |
| K120513 | Glow by Endymed | 2012 | 5 |
| K140926 | Inmode Wmface Device | 2014 | 3 |
| K121150 | Alma Lasers Family of Pixel RF Tips | 2012 | 3 |
| K110672 | Etwo Skin Treatment System | 2011 | 2 |
| K242996 | EndyMed PRO MAX | 2025 | 1 |
| K141507 | Two Skin Treatment System | 2014 | 0 |
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 14 years and passes through 6 companies; a new generation was cleared every 10 months on median.
- 3 of the 87 ancestors have a recall of any class.
- Of its descendants, K101510 (Endymed Medical, Ltd., 2011) has gone furthest, with 64 descendants of its own.
- 6 other devices also cite its predicate K051214.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Imagine TC Skin Treatment System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083461: Imagine TC Skin Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083461
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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