Device Classification Name |
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
|
510(k) Number |
K143339 |
Device Name |
Mini me |
Applicant |
ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.) |
KOCHAV YOKNEAM BLDG. YOKNEAM INDUSTRIAL ZONE |
YOKNEAM ILLIT,
IL
20692
|
|
Applicant Contact |
BOBAE KIM |
Correspondent |
HOGAN LOVELLS US LLP |
1835 MARKET ST., 29TH FL |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
JANICE M HOGAN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 11/20/2014 |
Decision Date | 12/19/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|