Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K233301 |
Device Name |
ULTRApulse Alpha CO2 Laser System, Delivery Devices and Accessories |
Applicant |
Lumenis Be Ltd. |
Hakidma Street 9, P.O.B. 426 |
Yokneam Industrial Park,
IL
2069236
|
|
Applicant Contact |
Shlomit Segman |
Correspondent |
Lumenis Be Ltd. |
Hakidma Street 9, P.O.B. 426 |
Yokneam Industrial Park,
IL
2069236
|
|
Correspondent Contact |
Shlomit Segman |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/29/2023 |
Decision Date | 12/01/2023 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|