ApprovalTrail

Medical device licence · 104861 · Class 3

ZYE ALEX

Yes: licensed in Canada

Licence status Issued (active); first licensed July 7, 2020. It is in Health Canada’s list of active licences.
Licence number
104861
Licence holder
Vydence Medical - Industria E Comercio LtdaSao Paulo, Brazil
Risk class
Class III (moderate to high risk)
Licence type
System
First licensed
July 7, 2020
Devices covered
22

Devices on this licence

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

  • 1064QS/532QS ND:YAG ACROMA LASER APPLICATOR
  • 3 - 10 ALEX AND YAG APPLICATOR
  • 3 - 24 ALEX AND YAG APPLICATOR
  • 8 - 18 ALEX AND YAG APPLICATOR
  • ALEXANDRITA 755 NM - INTERNAL CAVITY LASER
  • ATHENA 360
  • ATHENA 90+
  • ER:GLAS 1540 GOSMOOTH LASER APPLICATOR
  • ER:YAG 2940 DUALMODE LASER APPLICATOR
  • HANDPICO
  • INLIFT
  • INTENSE IR APPLICATOR
  • IPL-SQ FILTER 400 NM
  • IPL-SQ FILTER 515 NM
  • IPL-SQ FILTER 540 NM
  • IPL-SQ FILTER 580 NM
  • IPL-SQ FILTER 640 NM
  • IPL-SQ FILTER 695 NM
  • IPL-SQ INTENSE PULSED LIGHT APPLICATOR
  • ND:YAG 1064 LONGPULSE LASER APPLICATOR
  • ND:YAP 1340 PRODEEP LASER APPLICATOR
  • ZYE ALEX

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