Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K161257 |
Device Name |
MultiPulse HoPLUS |
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 | 05/04/2016 |
Decision Date | 03/31/2017 |
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
|