Device Classification Name |
Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
|
510(k) Number |
K131649 |
Device Name |
ME |
Applicant |
SYNERON BEAUTY LTD. |
1835 MARKET ST., 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Applicant Contact |
JANICE M HOGAN |
Correspondent |
SYNERON BEAUTY LTD. |
1835 MARKET ST., 29TH FLOOR |
PHILADELPHIA,
PA
19103
|
|
Correspondent Contact |
JANICE M HOGAN |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 06/05/2013 |
Decision Date | 12/11/2013 |
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
|