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
|
Predetermined Change Control Plan Authorized |
No
|