Medical device licence · 96295 · Class 2
INSTACLEAR, LENS CLEANER
Yes: licensed in Canada
Licence status Issued (active); first licensed December 18, 2015. It is in Health Canada’s list of active licences.
- Licence number
- 96295
- Licence holder
- Gyrus Acmi, IncWestborough, MA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- System
- First licensed
- December 18, 2015
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- INSTACLEAR CONSOLE
- INSTACLEAR FOOTPEDAL
- INSTACLEAR SHEATH
- INSTACLEAR TUBESET
Recalls and safety alerts that mention it
Health Canada’s recall notices do not carry licence numbers, so these are matched by name: notices whose title or product names “instaclear”. A notice may cover another product or only some lots: read it to see what it covers.
- InstaClear SheathMay 17, 2024 · Gastroenterology and urology · Performance · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.