Brand Name | SLIMLINE SIS |
Type of Device | POWERED LASER SURGICAL INSTRUMENT |
Manufacturer (Section D) |
LUMENIS LTD |
hakidma 6, |
yokneam 20692 04 |
IS 2069204 |
|
Manufacturer (Section G) |
LIGHT GUIDE OPTICS INTERNATIONAL LTD |
celtniecibas str 8 |
hakidma st 6 |
livani LV-53 16 |
LG
LV-5316
|
|
Manufacturer Contact |
farshad
fahimi
|
4100 hamline avenue north |
building c |
saint paul, MN 55112
|
|
MDR Report Key | 19009198 |
MDR Text Key | 339010477 |
Report Number | 2124215-2024-18610 |
Device Sequence Number | 1 |
Product Code |
GEX
|
UDI-Device Identifier | 07290109145556 |
UDI-Public | 07290109145556 |
Combination Product (y/n) | N |
Reporter Country Code | CH |
PMA/PMN Number | K170121 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Foreign,Health Professional |
Reporter Occupation |
Physician
|
Type of Report
| Initial,Followup |
Report Date |
05/01/2024 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 0644-017-01 |
Device Catalogue Number | 0644-017-01 |
Device Lot Number | 0084040122 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
03/19/2024
|
Initial Date FDA Received | 03/30/2024 |
Supplement Dates Manufacturer Received | 04/07/2024
|
Supplement Dates FDA Received | 05/01/2024
|
Was Device Evaluated by Manufacturer? |
No
|
Date Device Manufactured | 03/01/2022 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
|
|