Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K041959 |
Device Name |
POLARIS DS/COMET |
Applicant |
SYNERON MEDICAL LTD. |
POB 550 |
YOKNEAM ELITE,
IL
20692
|
|
Applicant Contact |
AMIR WALDMAN |
Correspondent |
SYNERON MEDICAL LTD. |
POB 550 |
YOKNEAM ELITE,
IL
20692
|
|
Correspondent Contact |
AMIR WALDMAN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 07/21/2004 |
Decision Date | 11/08/2004 |
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
|