Medical device licence · 101709 · Class 3
LIGHTSCALPEL CO2 LASER SYSTEM
Yes: licensed in Canada
Licence status Issued (active); first licensed September 6, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101709
- Licence holder
- Lightscalpel Inc.Bothell, WA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- September 6, 2018
- Devices covered
- 11
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- CO2 LASER WAVEGUIDE
- HANDPIECE FOCUSING
- HANDPIECE TIP RETAINER
- LIGHTSCALPEL EXTRA-LARGE SPOT HANDPIECE
- LIGHTSCALPEL LARGE SPOT TIP-LOCK HANDPIECE
- LIGHTSCALPEL TIP FOR CO2 LASER
- LS ADAPTER, FOCUSING LENS
- LS ADAPTER, TIP RETAINER
- LS-1005 CO2 LASER SYSTEM
- LS-2010 CO2 LASER SYSTEM
- TIP FOR CO2 LASER
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.