Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K170060 |
Device Name |
M22 and ResurFx Systems |
Applicant |
LUMENIS, LTD. |
6 HAKIDMA STREET |
PO Box 240 |
YOKNEAM,
IL
2069204
|
|
Applicant Contact |
Naama Jacoby |
Correspondent |
LUMENIS, LTD. |
6 HAKIDMA STREET |
PO Box 240 |
YOKNEAM,
IL
2069204
|
|
Correspondent Contact |
Naama Jacoby |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 01/06/2017 |
Decision Date | 08/09/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|