Medical device licence · 111990 · Class 3
ACUPULSE
Yes: licensed in Canada
Licence status Issued (active); first licensed October 11, 2024. It is in Health Canada’s list of active licences.
- Licence number
- 111990
- Licence holder
- Lumenis Be Ltd.Yokneam, Israel
- Risk class
- Class III (moderate to high risk)
- Licence type
- System
- First licensed
- October 11, 2024
- Devices covered
- 21
Devices on this licence
By name, as listed. The official record lists model numbers and identifiers.
- ACUPULSE
- ACUPULSE INCISIONAL HANDPIECE
- ACUPULSE UPGRADE KIT 40 TO 40AES-F
- ACUPULSE UPGRADE KIT 40 TO 40AES-R
- ACUPULSE UPGRADE KIT 40AES-F TO 40AES-R
- ACUSCAN120 MICROSCANNER KIT
- ACUSCAN120 MICROSCANNER KIT, FIELD UPGRADE
- ACUSCAN120 MICROSCANNER KIT, REPLACEMENT
- ACUSCAN120 MICROSCANNER KIT, UPGRADE
- FEMTOUCH FINE FOCUS DISPOSABLE TIP
- FEMTOUCH FINE FOCUS TIP KIT
- FEMTOUCH FINE PANORAMIC DISPOSABLE TIP
- FEMTOUCH FINE PANORAMIC TIP KIT
- FEMTOUCH STANDARD FOCUS TIP KIT
- FEMTOUCH STANDARD PANORAMIC TIP KIT
- FEMTOUCH STD. FOCUS DISPOSABLE TIP
- FEMTOUCH STD. PANORAMIC DISPOSABLE TIP
- SURGITOUCH SCANNER
- SURGITOUCH SCANNER KIT
- SURGITOUCH SCANNER, REPLACEMENT
- SURGITOUCH SCANNING HANDPIECE SET
Class I devices, the lowest-risk group, mostly need no device licence, so most are not in this list.