Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K192951 |
Device Name |
Ellipse Frax 1940 for Ellipse Nordlys and Ellipse Ydun |
Applicant |
Ellipse A/S |
Agern Alle 11 |
Hoersholm,
DK
dk-2970
|
|
Applicant Contact |
Ole Kofod |
Correspondent |
Ellipse A/S |
Agern Alle 11 |
Hoersholm,
DK
dk-2970
|
|
Correspondent Contact |
Ole Kofod |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 10/21/2019 |
Decision Date | 03/26/2020 |
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
|