Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
510(k) Number |
K120510 |
Device Name |
TRANSCEND |
Applicant |
SYNERON MEDICAL LTD. |
INDUSTRIAL ZONE, TAVOR |
BUILDING, P.O.B. 550 |
YOKNEAM ILLIT,
IL
20692
|
|
Applicant Contact |
SAM WADE |
Correspondent |
SYNERON MEDICAL LTD. |
INDUSTRIAL ZONE, TAVOR |
BUILDING, P.O.B. 550 |
YOKNEAM ILLIT,
IL
20692
|
|
Correspondent Contact |
SAM WADE |
Regulation Number | 878.4400
|
Classification Product Code |
|
Date Received | 02/21/2012 |
Decision Date | 07/19/2013 |
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
|
|
|