Medical device licence · 109385 · Class 3
PROFOUND MATRIX
Yes: licensed in Canada
Licence status Issued (active); first licensed May 25, 2023. It is in Health Canada’s list of active licences.
- Licence number
- 109385
- Licence holder
- Candela CorporationWayland, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- May 25, 2023
- Devices covered
- 10
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- FOCAL 44 SUBLATIVE ID (200 PULSE)
- MATRIX PRO APPLICATOR, PROFOUND MATRIX
- MATRIX PRO CARTRIDGE BOX
- MATRIX PRO CARTRIDGE TIP
- PROFOUND MATRIX
- STANDARD 64 SUBLATIVE ID (100 PULSE)
- STANDARD 64 SUBLATIVE ID (200 PULSE)
- STANDARD 64 SUBLATIVE ID (400 PULSE)
- SUBLATIVE RF APPLICATOR, PROFOUND MATRIX
- SUBLIME APPLICATOR, PROFOUND MATRIX
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.