Medical device licence · 75833 · Class 3
GENTLEMAX LASER
Yes: licensed in Canada
Licence status Issued (active); first licensed December 10, 2007. It is in Health Canada’s list of active licences.
- Licence number
- 75833
- Licence holder
- Candela CorporationWayland, MA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- December 10, 2007
- Devices covered
- 23
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACC HANDPIECE
- DCD HANDPIECE
- GENTLELASE PRO-U LASER SYSTEM
- GENTLEMAX PRO LASER SYSTEM
- GENTLEMAX PRO PLUS LASER SYSTEM
- GENTLEYAG PRO-U LASER SYSTEM
- GMPP ACC HP AIR CLIT KIT
- GMPP ACC LARGE SPOT OPTION KIT
- GMPP ACC MEDIUM SPOT OPTION KIT
- GMPP DCD LARGE SPOT OPTION KIT
- GMPP DCD SMALL SPOT OPTION KIT
- LARGE SPOT DELIVERY SYSTEM
- LARGE SPOT FIBER ASSEMBLY
- LARGE SPOT SPECIALTY DELIVERY SYSTEM ASSEMBLY
- MSDS DCD OPTIONS KIT GMPP
- PF1 6-18MM HANDPIECE DELIVERY SYSTEM W/DCD
- PRO SERIES DCD HP W/O FIBER, REFURBISHED
- PRO SERIES DELIVERY SYSTEM
- PRO SERIES FIBER ASSEMBLY
- PRO SERIES HANDPIECE
- REFURBISHED GENTLE MAX PRO LASER SYSTEM
- REFURBISHED GENTLEMAX PRO PLUS LASER SYSTEM
- SPECIALTY DELIVERY SYSTEM ASSEMBLY
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.