Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K170179 |
Device Name |
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity |
Applicant |
Lumenis Ltd. |
6 Hakidma Street PO Box 240 |
Yokneam,
IL
2069204
|
|
Applicant Contact |
Amaya De Levie |
Correspondent |
Lumenis Ltd. |
6 Hakidma Street PO Box 240 |
Yokneam,
IL
2069204
|
|
Correspondent Contact |
Amaya De Levie |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/19/2017 |
Decision Date | 09/18/2017 |
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
|