Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K212703 |
Device Name |
AcuPulse CO2 Laser System, Delivery Devices and Accessories |
Applicant |
Lumenis, Ltd. |
6 Hakidma Street PO Box 240 |
Yokneam,
IL
2069204
|
|
Applicant Contact |
Shlomit Segman |
Correspondent |
Lumenis, Ltd. |
6 Hakidma Street PO Box 240 |
Yokneam,
IL
2069204
|
|
Correspondent Contact |
Shlomit Segman |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/26/2021 |
Decision Date | 10/19/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|