Medical device licence · 78510 · Class 3
COOLSCULPTING SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed November 21, 2008. It is in Health Canada’s list of active licences.
- Licence number
- 78510
- Licence holder
- Zeltiq Aesthetics, Inc.Pleasanton, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- November 21, 2008
- Devices covered
- 7
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- COOLSCULPTING SYSTEM - APPLICATOR - SURFACE
- COOLSCULPTING SYSTEM - APPLICATOR - VACUUM
- COOLSCULPTING SYSTEM - CONTROL UNIT
- COOLSCULPTING SYSTEM - GELPADS
- COOLSCULPTING SYSTEM - INITIAL STARTER PACK
- COOLSCULPTING SYSTEM - LINER
- COOLSCULPTING SYSTEM - RECORDER PACK
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “coolsculpting”. A notice may cover another product or only some lots: read it to see what it covers.
- Coolsculpting System - Applicator - VacuumJune 20, 2022 · Physical medicine · Performance · Type II
- CoolSculpting System (also known as ZELTIQ Breeze System (2014-07-18)August 8, 2014 · Medical devices · Medical devices · Type III
- Coolsculpting System and Applicator, (Aka. Zeltiq Breeze System)(2012-08-06)November 7, 2013 · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.