Medical device licence · 609 · Class 3
SOVEREIGN PHACOEMULSIFICATION & ACCESSORIES
Yes: licensed in Canada
Licence status Issued (active); first licensed January 8, 1999. It is in Health Canada’s list of active licences.
- Licence number
- 609
- Licence holder
- Johnson & Johnson Surgical Vision, Inc.Irvine, CA, United States
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- January 8, 1999
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- PHACOFIT MULTI-TIP IRRIGATION/ASPIRATION HANDPIECE SET
- SOVEREIGN PHACOEMULSIFICATION SYSTEM
- SOVEREIGN PHACOEMULSIFICATION SYSTEM - HANDPIECES
- SOVEREIGN PHACOEMULSIFICATION SYSTEM - VERSION 7.0 SOFTWARE W/WHITESTAR ICE
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.