Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K161632 |
Device Name |
FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) |
Applicant |
BIOS S.R.L. |
VIA GUIDO ROSSA, 10/12 |
VIMODRONE,
IT
I-20090
|
|
Applicant Contact |
Riccardo Pisati |
Correspondent |
BIOS S.R.L. |
VIA GUIDO ROSSA, 10/12 |
VIMODRONE,
IT
I-20090
|
|
Correspondent Contact |
Riccardo Pisati |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 06/13/2016 |
Decision Date | 12/08/2016 |
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
|
|
|