ApprovalTrail

Medical device licence · 81642 · Class 3

KONA LASER SYSTEM

No longer licensed: cancelled: renewal not answered

Licence status Cancelled: renewal not answered; first licensed January 6, 2010; ended October 31, 2017. It is in Health Canada’s archive of licences no longer in force.
Licence number
81642
Licence holder
Radiancy Israel Ltd.Hod Hasharon, Israel
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
January 6, 2010
Ended
October 31, 2017
Devices covered
8

Devices on this licence

By name, as listed. The official record lists model numbers and identifiers.

  • KONA SYSTEM
  • KONA SYSTEM - AREA ADAPTOR ASSY
  • KONA SYSTEM - FOOT SWITCH
  • KONA SYSTEM - HANDPIECE HR XL
  • KONA SYSTEM - HANDPIECE HR/SR
  • KONA SYSTEM - HANDPIECE HR/SR FOR SKIN TYPES (V-VI)
  • KONA SYSTEM - HYGIENIC RINGS
  • KONA SYSTEM - MAIN UNIT

Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.