Device Classification Name |
massager, vacuum, light induced heating
|
510(k) Number |
K053611 |
Device Name |
SMOOTHSHAPES |
Applicant |
BICELLULASE, INC. |
21 PARK AVE. |
NEWTON,
MA
02458
|
|
Applicant Contact |
ROBERT NAGEL |
Correspondent |
BICELLULASE, INC. |
21 PARK AVE. |
NEWTON,
MA
02458
|
|
Correspondent Contact |
ROBERT NAGEL |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 12/27/2005 |
Decision Date | 03/15/2006 |
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
|
|
|