Device Classification Name |
electrosurgical, cutting & coagulation & accessories
|
510(k) Number |
K130793 |
Device Name |
NEWA SKIN THERAPY SYSTEM |
Applicant |
ENDYMION MEDICAL LTD |
31 HAAVODA ST. |
BINYAMINA,
IL
30500
|
|
Applicant Contact |
YORAM LEVY |
Correspondent |
ENDYMION MEDICAL LTD |
31 HAAVODA ST. |
BINYAMINA,
IL
30500
|
|
Correspondent Contact |
YORAM LEVY |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 03/22/2013 |
Decision Date | 08/16/2013 |
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
|