# K014253: Dermachiller 4

- Pathway: 510(k) (Traditional)
- Applicant: Paradigm Trex, LLC
- Decided: Mar 26, 2002 after 90 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K963094 (1996). 27 ancestors in all.
50 later devices descend from it; 3 cite it directly.
0 of 78 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984110: Laserscope Coolspot, Laserscope (1998) Summary page 1.
- K001589: Candela Dynamic Cooling Device, Candela Corp. (2000) Summary page 1.
- K990417: Dermacool, Optomed Corp. (1999) Summary page 1.

## Most influential descendants
- K040727: CRYO 5 (2004), 48 descendants of its own
- K060407: Juniper Cooling Device (2006), 36 descendants of its own
- K063715: Juniper Cooling Device Xtra (2007), 35 descendants of its own
- K072152: Juniper CLN1 Dermal Cooling Device (2007), 34 descendants of its own
- K080118: Zeltiq Aesthetics CLN1 Dermal Cooling Device (2008), 33 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K014253
Methodology: https://510kreport.com/methodology