Device Classification Name |
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
|
510(k) Number |
K090399 |
Device Name |
TRIOS SYSTEM |
Applicant |
VIORA LTD. |
30 MONTGOMERY STREET |
SUITE 660 |
JERSEY CITY,
NJ
07302
|
|
Applicant Contact |
JOSEF LUZON |
Correspondent |
VIORA LTD. |
30 MONTGOMERY STREET |
SUITE 660 |
JERSEY CITY,
NJ
07302
|
|
Correspondent Contact |
JOSEF LUZON |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/17/2009 |
Decision Date | 06/10/2009 |
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
|