510(k) · Cleared
ClearedZeltiq System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeltiq Aesthetics · GEX Powered Laser Surgical Instrument
Cleared on May 20, 2009 as substantially equivalent to K080118 (Zeltiq Aesthetics, 2008) after a 126-day review. Its family tree reaches back 15 generations to 1995. 32 later devices descend from it.
- Decided
- May 20, 2009
- Review
- 126 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K943450 (1995). 126 ancestors in all, the oldest K800617 (1980). 32 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
- 2 generations backK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- 1 generation backK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- This deviceK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- Descendant · cites it directly · 31 of its ownK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
- Descendant · 2 generations on · 30 of its ownK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- Descendant · 2 generations on · 27 of its ownK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- Descendant · 2 generations on · 26 of its ownK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- Descendant · 3 generations on · 21 of its ownK150724 SculpSureCynosure, Inc. · 2015
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- 3 generations backK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
- 2 generations backK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- 1 generation backK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- This deviceK090094 Zeltiq SystemZeltiq Aesthetics · 2009
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K120023Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012 · cites it directly31descendants
- K133212Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014 · 2 generations on30descendants
- K142491ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015 · 2 generations on27descendants
- K151179ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015 · 2 generations on26descendants
- K150724SculpSureCynosure, Inc. · 2015 · 3 generations on21descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| −3 | K051710 | Thermage Thermacool Coupling Fluid | Thermage, Inc. | 2005 | — |
| −2 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| −1 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| 0 (this device) | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| +1 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
| +2 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
| +2 | K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| +2 | K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| +3 | K150724 | SculpSure | Cynosure, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 10 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 13 | 0 |
| 1998 | 11 | 0 |
| 1999 | 6 | 0 |
| 2000 | 10 | 0 |
| 2001 | 3 | 0 |
| 2002 | 9 | 0 |
| 2003 | 5 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 3 | 0 |
| 2025 | 1 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling DeviceSummary page 1…ctric PREDICATE DEVICE: The Zeltiq System is substantially equivalent to the Zeltiq CLN1I Dermal Cooling Device (K0801 18). SUBSTANTIALLY EQUIVALENT To: The Zeltiq System has the same intended use and mechanism of action to the Zeltiq… | 2008 |
What descends from it? (32)
See all 321 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K120023 | Zeltiq Coolsculpting | 2012 | 31 |
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 4 companies; a new generation was cleared every 9 months on median.
- 4 of the 126 ancestors have a recall of any class.
- Of its descendants, K120023 (Zeltiq Aesthetics, Inc., 2012) has gone furthest, with 31 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The Zeltiq System is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltiq System can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms.…
Read the full statement (125 words)
The Zeltiq System is intended for use as a skin cooling device to minimize pain and thermal injury during laser and dermatological treatments. Alternative uses include skin cooling as a local anesthetic for procedures that induce minor local discomfort. The Zeltiq System can also provide localized thermal therapy (hot or cold) to minimize pain for post traumatic and/or post surgical pain and to temporarily relieve minor aches and pains and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm, for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.
Zeltiq Gel facilitates thermal contact of the Zeltiq System with a patient's skin by mitigating minor variances in device-to-skin contact.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090094 · printed Nov 4, 2026
Cite this page
510(k) Report. “K090094: Zeltiq System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K090094
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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