510(k) · Cleared
ClearedJuniper Cooling Device Xtra
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Juniper Medical, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Feb 5, 2007 as substantially equivalent to K060407 (Juniper Medical Technology, Inc., 2006) and 3 other predicates after a 53-day review. Its family tree reaches back 10 generations to 1992. 35 later devices descend from it.
- Decided
- Feb 5, 2007
- Review
- 53 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 10 generations to K910422 (1992). 91 ancestors in all, the oldest K880042 (1988). 35 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 2 generations backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- 1 generation backK060407 Juniper Cooling DeviceJuniper Medical Technology, Inc. · 2006
- This deviceK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
- Descendant · cites it directly · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- Descendant · 2 generations on · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
- Descendant · 3 generations on · 32 of its ownK090094 Zeltiq SystemZeltiq Aesthetics · 2009
- Descendant · 4 generations on · 31 of its ownK120023 Zeltiq CoolsculptingZeltiq Aesthetics, Inc. · 2012
- Descendant · 5 generations on · 30 of its ownK133212 Zeltiq Coolsculpting SystemZeltiq Aesthetics, Inc. · 2014
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 5 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 4 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 3 generations backK032460 Profile BBL SystemSciton, Inc · 2003
- 2 generations backK050047 Cutera Optional Pulsed Light Hand Piece FamilyCutera, Inc. · 2005
- 1 generation backK060407 Juniper Cooling DeviceJuniper Medical Technology, Inc. · 2006
- This deviceK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −5 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −4 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −3 | K032460 | Profile BBL System | Sciton, Inc | 2003 | — |
| −2 | K050047 | Cutera Optional Pulsed Light Hand Piece Family | Cutera, Inc. | 2005 | — |
| −1 | K060407 | Juniper Cooling Device | Juniper Medical Technology, Inc. | 2006 | — |
| 0 (this device) | K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | 2007 | — |
| +1 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| +2 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
| +3 | K090094 | Zeltiq System | Zeltiq Aesthetics | 2009 | — |
| +4 | K120023 | Zeltiq Coolsculpting | Zeltiq Aesthetics, Inc. | 2012 | — |
| +5 | K133212 | Zeltiq Coolsculpting System | Zeltiq Aesthetics, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 5 | 0 |
| 1993 | 3 | 0 |
| 1994 | 8 | 0 |
| 1995 | 7 | 0 |
| 1996 | 8 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 5 | 0 |
| 2000 | 7 | 0 |
| 2001 | 3 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 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? (5)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K060407 | Juniper Cooling DeviceSummary page 1…evice XTRA is substantially equivalent in intended use and mechanism of action to the Juniper Cooling Device (K060407) and the MediSeb's ElfCare thermal therapy device for both hot and cold… | 2006 |
| * | K023231 | Elfcare Device, Models 314A Through 314GSummary page 1…Cooling Device (K060407) and the MediSeb's ElfCare thermal therapy device for both hot and cold applications (K02323 1, cleared on April 4th 2003). The device is also substantially equivalent to the Cynosure… | 2003 |
| * | K030876 | Cynosure Triactive Therapeutic Massage SystemSummary page 1…April 4th 2003). The device is also substantially equivalent to the Cynosure Triactive Therapeutic massager (K030876). Also included in this submission is the Juniper Medical Coupling Gel,… | 2004 |
| Kept off the family tree | K051170 | FDA’s K051170 is Gemini GXL Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 2005 |
| * | K961222 | Evron GelSummary page 1…ol System (KO5 170), and is substantially equivalent in composition to Pharmaceutical Innovation's Evron Gel (K961222). SUBSTANTIALLY EQUIVALENT To: The Juniper Cooling Device XTRA is substantially equivalent in intended use and mechanism of act… | 1996 |
What descends from it? (35)
See all 351 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072152 | Juniper CLN1 Dermal Cooling Device | 2007 | 34 |
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 15 years and passes through 9 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 91 ancestors has a recall of any class.
- Of its descendants, K072152 (Juniper Medical, Inc., 2007) has gone furthest, with 34 descendants of its own.
- 1 other device also cites its predicate K060407.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Juniper Cooling Device XTRA 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 Juniper Cooling Device XTRA 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…
Read the full statement (136 words)
The Juniper Cooling Device XTRA 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 Juniper Cooling Device XTRA 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 relief of minor muscle aches, pain, and spasm and for the improvement in local circulation and temporary reduction in the appearance of cellulite.
The Juniper Medical Coupling Gel facilitates thermal contact of the Juniper Cooling Device XTRA 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/K063715 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063715: Juniper Cooling Device Xtra.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063715
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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