Dermachiller FDA 510(k)


#1

In April 2002, FDA cleared a new dermatological chiller for use with lasers. It’s marketed by Paradigm Trex, whose medical director, Nikolai Tankovich, was involved with the ill-fated Thermolase Softlight.

These devices appear to reduce pain and side effects associated with laser hair removal, and may increase effectiveness by allowing higher energy levels to be used in treatment.

510(k) Number K014253
Device Name DERMACHILLER 4
Applicant
PARADIGM TREX, LLC
10455 PACIFIC CENTER CT.
SAN DIEGO, CA 92121 4339Contact NIKOLAI TANKOVICH
Product Code GEX
Date Received 12/26/2001
Decision Date 03/26/2002
Decision SUBSTANTIALLY EQUIVALENT (SE)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Statement/Summary/Purged Status Summary only
SUMMARY/Approval Letter SUMMARY
Type Traditional
Reviewed by Third Party No
Expedited Review

Substantially equivalent devices:

Coolspot K984110
Dynamic Cooling Device K001589
Dermacool K990417

[ May 07, 2002, 01:04 PM: Message edited by: Andrea ]