Medical device licence · 70947 · Class 2
OPTILITE HOLMIUM FIBER ASSEMBLIES
Yes: licensed in Canada
Licence status Issued (active); first licensed March 27, 2006. It is in Health Canada’s list of active licences.
- Licence number
- 70947
- Licence holder
- Xintec CorporationAlameda, CA, United States
- Risk class
- Class II (low to moderate risk)
- Licence type
- Device Family
- First licensed
- March 27, 2006
- Devices covered
- 4
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- OPTILITE ANGLED DELIVERY HOLMIUM FIBER ASSEMBLY
- OPTILITE HOLMIUM FIBER ASSEMBLY
- OPTILITE MULTI USE HOLMIUM LASER FIBERS
- OPTILITE SIUNGLE USE HOLMIUM LASER FIBERS
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 “optilite”. A notice may cover another product or only some lots: read it to see what it covers.
- Optilite Analyser (2020-04-09)May 1, 2020 · Medical devices · Medical devices · Type III
- Optilite Low Level Albumin Kit (2019-12-19)January 10, 2020 · Medical devices · Medical devices · Type III
- Optilite IgM Kit (2019-07-19)August 16, 2019 · Medical devices · Medical devices · Type III
- Optilite Beta-2-microglobulin Urine Kit (2018-03-09)April 3, 2018 · Medical devices · Medical devices · Type II
- Optilite Holmium Fiber Assembly and Lser Fibers (2017-06-13)July 7, 2017 · Medical devices · Medical devices · Type II
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.