Medical device licence · 101239 · Class 3
IDESIGN REFRACTIVE STUDIO
Yes: licensed in Canada
Licence status Issued (active); first licensed June 19, 2018. It is in Health Canada’s list of active licences.
- Licence number
- 101239
- Licence holder
- Amo Manufacturing Usa, LlcIrvine, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- June 19, 2018
- Devices covered
- 5
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- IDESIGN REFRACTIVE STUDIO ABERROMETER
- IDESIGN REFRACTIVE STUDIO SYSTEM
- IDESIGN REFRACTIVE STUDIO TABLE
- IDESIGN REFRACTIVE STUDIO TABLE UPGRADE ACCESSORIES
- IDESIGN REFRACTIVE STUDIO UPGRADE KIT
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 “idesign”. A notice may cover another product or only some lots: read it to see what it covers.
- The iDESIGN Refractive StudioNovember 26, 2021 · Ophthalmology · Software defect · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.