Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K143519 |
Device Name |
The MeDioStar NeXT Family |
Applicant |
ASCLEPION LASER TECHNOLOGIES GMBH |
BRUESSELER STR. 10 |
jena,
DE
07747
|
|
Applicant Contact |
antje katzer |
Correspondent |
ASCLEPION LASER TECHNOLOGIES GMBH |
BRUESSELER STR. 10 |
jena,
DE
07747
|
|
Correspondent Contact |
antje katzer |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 12/12/2014 |
Decision Date | 03/10/2015 |
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
|