ApprovalTrail

Medical device licence · 92477 · Class 3

EPIC DIODE LASER SYSTEM

Yes: licensed in Canada

Licence status Issued (active); first licensed December 18, 2013. It is in Health Canada’s list of active licences.
Licence number
92477
Licence holder
Biolase Mg Llc.Foothill Ranch, CA, United States
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
December 18, 2013
Devices covered
7

Devices on this licence

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

  • EPIC SYSTEM - BATTERY PACK
  • EPIC SYSTEM - CONSOLE
  • EPIC SYSTEM - FIBER OPTIC ASSEMBLY
  • EPIC SYSTEM - HANDPIECE
  • EPIC SYSTEM - OPTICAL ACCESS PLUG
  • EPIC SYSTEM - POWER CORD WITH POWER SUPPLY
  • EPIC SYSTEM - WIRELESS FOOTSWITCH

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