510(k) · Cleared
ClearedZELTIQ CoolSculpting System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zeltiq Aesthetics, Inc. · OOK Dermal Cooling Pack/Vacuum/Massager
Cleared on Mar 23, 2016 as substantially equivalent to K151179 (Zeltiq Aesthetics, Inc., 2015) after a 51-day review. Its family tree reaches back 20 generations to 1995. 15 later devices descend from it.
- Decided
- Mar 23, 2016
- Review
- 51 days
- Class
- Class II
- Product code
- OOK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 20 generations to K943450 (1995). 132 ancestors in all, the oldest K800617 (1980). 15 later devices descend from it, 1 citing it directly.
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 16 generations between
- 3 generations backK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- 2 generations backK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 1 generation backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- This deviceK160259 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2016
- Descendant · cites it directly · 14 of its ownK162050 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2016
- Descendant · 2 generations on · 10 of its ownK171111 SculpsureCynosure, Inc. · 2017
- Descendant · 2 generations on · 8 of its ownK171992 SculpSureCynosure, Inc. · 2017
- Descendant · 2 generations on · 8 of its ownK171069 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2017
- Descendant · 3 generations on · 7 of its ownK172144 CoolSculpting SystemZeltiq Aesthetics · 2017
Show all 20 generations
- Root · 20 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 18 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 16 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 15 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 14 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 13 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 12 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 11 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 9 generations backK033942 Thermage Thermacool SystemThermage, Inc. · 2004
- 8 generations backK051710 Thermage Thermacool Coupling FluidThermage, Inc. · 2005
- 7 generations backK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- 6 generations backK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- 5 generations backK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- 4 generations backK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
- 3 generations backK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
- 2 generations backK142491 ZEL TIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- 1 generation backK151179 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2015
- This deviceK160259 ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2016
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K162050ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2016 · cites it directly14descendants
- K171111SculpsureCynosure, Inc. · 2017 · 2 generations on10descendants
- K171992SculpSureCynosure, Inc. · 2017 · 2 generations on8descendants
- K171069ZELTIQ CoolSculpting SystemZeltiq Aesthetics, Inc. · 2017 · 2 generations on8descendants
- K172144CoolSculpting SystemZeltiq Aesthetics · 2017 · 3 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −19 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −18 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −16 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −15 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −14 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −13 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −12 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −11 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −9 | K033942 | Thermage Thermacool System | Thermage, Inc. | 2004 | — |
| −8 | K051710 | Thermage Thermacool Coupling Fluid | Thermage, Inc. | 2005 | — |
| −7 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| −6 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| −5 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| −4 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
| −3 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
| −2 | K142491 | ZEL TIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| −1 | K151179 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2015 | — |
| 0 (this device) | K160259 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016 | — |
| +1 | K162050 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2016 | — |
| +2 | K171111 | Sculpsure | Cynosure, Inc. | 2017 | — |
| +2 | K171992 | SculpSure | Cynosure, Inc. | 2017 | — |
| +2 | K171069 | ZELTIQ CoolSculpting System | Zeltiq Aesthetics, Inc. | 2017 | — |
| +3 | K172144 | CoolSculpting System | Zeltiq Aesthetics | 2017 | — |
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 |
| 2010 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 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 OOK? 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 OOK device
- #1 K233732 CoolSculpting Elite Systemscore 8.6 · 3 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 |
|---|---|---|---|
| * | K151179 | ZELTIQ CoolSculpting SystemSummary page 4…Aesthetic Use DEVICE CLASSIFICATION: Class II, 21 CFR §878.4340 PRODUCT CODE: OOK PREDICATE DEVICES: The ZELTIQ CoolSculpting System (K151179) DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The CoolSculpting System is a portable thermoelectric cooling and… | 2015 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162050 | ZELTIQ CoolSculpting System | 2016 | 14 |
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 21 years and passes through 5 companies; a new generation was cleared every 10 months on median.
- 4 of the 132 ancestors have a recall of any class.
- Of its descendants, K162050 (Zeltiq Aesthetics, Inc., 2016) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K151179.
How does its category compare?
All OOK devicesOOK Dermal Cooling Pack/Vacuum/Massager: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OOK
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · OOK
Too few OOK 510(k)s in any year since 2007 to give a median.
Recalls per year · OOK
No recall names OOK since 2007.
Adverse event reports per year · OOK
901in 2025
MAUDE reports naming product code OOK, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 1 | — | 0 | 32 |
| 2013 | 0 | — | 0 | 29 |
| 2014 | 1 | — | 0 | 5 |
| 2015 | 2 | — | 0 | 8 |
| 2016 | 2 | — | 0 | 21 |
| 2017 | 2 | — | 0 | 9 |
| 2018 | 1 | — | 0 | 10 |
| 2019 | 1 | — | 0 | 49 |
| 2020 | 1 | — | 0 | 18 |
| 2021 | 1 | — | 0 | 1,161 |
| 2022 | 0 | — | 0 | 1,978 |
| 2023 | 0 | — | 0 | 5,499 |
| 2024 | 1 | — | 0 | 1,277 |
| 2025 | 0 | — | 0 | 901 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The CoolSculpting System is a skin cooling or heating device. The device is indicated for cold-assisted lipolysis (breakdown of fat) of bra fat, back fat, banana roll, submental area, thigh, abdomen, and flank, or “love handles” in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in bra fat, back fat, banana roll, submental area, thigh, abdomen and flank. Cooling with the device…
Read the full statement (196 words)
The CoolSculpting System is a skin cooling or heating device. The device is indicated for cold-assisted lipolysis (breakdown of fat) of bra fat, back fat, banana roll, submental area, thigh, abdomen, and flank, or “love handles” in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in bra fat, back fat, banana roll, submental area, thigh, abdomen and flank.
Cooling with the device may also be used to minimize pain and thermal injury during laser and dermatological treatments and act as a local anesthetic for procedures that induce minor local discomfort.
The CoolSculpting System is also indicated for use to provide localized thermal therapy (hot or cold) to minimize pain post-trauma and post-surgery, and for temporary relief of minor aches, pains, and muscle spasms. The optional massage function can also be used for the temporary relief of minor muscle aches, pain, and spasm and for temporary improvement in local circulation and temporary reduction in the appearance of cellulite.
The ZELTIQ Pretreatment Skin Wipe and Gel/Gelpad facilitate thermal contact of the device 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/K160259 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160259: ZELTIQ CoolSculpting System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160259
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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