510(k) · Cleared
ClearedDermachiller 4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paradigm Trex, LLC · GEX Powered Laser Surgical Instrument
Cleared on Mar 26, 2002 as substantially equivalent to K984110 (Laserscope, 1998) and 2 other predicates after a 90-day review. Its family tree reaches back 4 generations to 1996. 50 later devices descend from it.
- Decided
- Mar 26, 2002
- Review
- 90 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K963094 (1996). 27 ancestors in all, the oldest K904627 (1991). 50 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK963094 Cynosure Photogenica LP Dermatological Vascular Lesion LaserCynosure, Inc. · 1996
- 3 generations backK972767 Candela Gentlelase GL Dermatological Vascular Lesion LaserCandela Corp. · 1997 · Recalled
- 2 generations backK974381 Candela Gentlelase GL Dermatological LaserCandela Corp. · 1998
- 1 generation backK990417 DermacoolOptomed Corp. · 1999
- This deviceK014253 Dermachiller 4Paradigm Trex, LLC · 2002
- Descendant · cites it directly · 48 of its ownK040727 CRYO 5Zimmer Elektromedizin GmbH · 2004
- Descendant · cites it directly · 36 of its ownK060407 Juniper Cooling DeviceJuniper Medical Technology, Inc. · 2006
- Descendant · 2 generations on · 35 of its ownK063715 Juniper Cooling Device XtraJuniper Medical, Inc. · 2007
- Descendant · 2 generations on · 34 of its ownK072152 Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007
- Descendant · 3 generations on · 33 of its ownK080118 Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008
Showing 5 of 50 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 50 · See all- K040727CRYO 5Zimmer Elektromedizin GmbH · 2004 · cites it directly48descendants
- K060407Juniper Cooling DeviceJuniper Medical Technology, Inc. · 2006 · cites it directly36descendants
- K063715Juniper Cooling Device XtraJuniper Medical, Inc. · 2007 · 2 generations on35descendants
- K072152Juniper CLN1 Dermal Cooling DeviceJuniper Medical, Inc. · 2007 · 2 generations on34descendants
- K080118Zeltiq Aesthetics CLN1 Dermal Cooling DeviceZeltiq Aesthetics · 2008 · 3 generations on33descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K963094 | Cynosure Photogenica LP Dermatological Vascular Lesion Laser | Cynosure, Inc. | 1996 | — |
| −3 | K972767 | Candela Gentlelase GL Dermatological Vascular Lesion Laser | Candela Corp. | 1997 | 1 |
| −2 | K974381 | Candela Gentlelase GL Dermatological Laser | Candela Corp. | 1998 | — |
| −1 | K990417 | Dermacool | Optomed Corp. | 1999 | — |
| 0 (this device) | K014253 | Dermachiller 4 | Paradigm Trex, LLC | 2002 | — |
| +1 | K040727 | CRYO 5 | Zimmer Elektromedizin GmbH | 2004 | — |
| +1 | K060407 | Juniper Cooling Device | Juniper Medical Technology, Inc. | 2006 | — |
| +2 | K063715 | Juniper Cooling Device Xtra | Juniper Medical, Inc. | 2007 | — |
| +2 | K072152 | Juniper CLN1 Dermal Cooling Device | Juniper Medical, Inc. | 2007 | — |
| +3 | K080118 | Zeltiq Aesthetics CLN1 Dermal Cooling Device | Zeltiq Aesthetics | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 3 | 0 |
| 1993 | 2 | 0 |
| 1994 | 7 | 0 |
| 1995 | 4 | 0 |
| 1996 | 4 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 0 |
| 2009 | 3 | 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 | 6 | 0 |
| 2023 | 3 | 0 |
| 2024 | 5 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (3)
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 |
|---|---|---|---|
| * | K984110 | Laserscope CoolspotSummary page 1…ative uses include skin cooling as a local - anesthetic for procedures that induce minor local discomfort. Substantial Equivalence Claim to: 1. CoolSpot — 510(k) Number K984110 2. Dynamic Cooling Device — 510(k) Number K001589 3. DermaCool- 510(k) Number K990417 RCLN DEPARTMENT OF HEALTH… | 1998 |
| * | K001589 | Candela Dynamic Cooling DeviceSummary page 1…hetic for procedures that induce minor local discomfort. Substantial Equivalence Claim to: 1. CoolSpot — 510(k) Number K984110 2. Dynamic Cooling Device — 510(k) Number K001589 3. DermaCool- 510(k) Number K990417 RCLN DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service el . ’ ' -… | 2000 |
| * | K990417 | DermacoolSummary page 1…or local discomfort. Substantial Equivalence Claim to: 1. CoolSpot — 510(k) Number K984110 2. Dynamic Cooling Device — 510(k) Number K001589 3. DermaCool- 510(k) Number K990417 RCLN DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service el . ’ ' - ‘ Food and Drug Administration 9200… | 1999 |
What descends from it? (50)
See all 503 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K040727 (Zimmer Elektromedizin GmbH, 2004) has gone furthest, with 48 descendants of its own.
- 3 other devices also cite its predicate K984110.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 DermacChiller 4 is intended as a skin-cooling device to minimize pain and thermal injury during laser and dermatological treatments and for temporary topical anesthetic relief for injections.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K014253 · printed Nov 3, 2026
Cite this page
510(k) Report. “K014253: Dermachiller 4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K014253
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026