Device Classification Name |
System, Suction, Lipoplasty
|
510(k) Number |
K171242 |
Device Name |
Alma LipoFlow System |
Applicant |
Alma Lasers Inc. |
485 Half Day Rd, Suite # 100 |
Buffalo Grove,
IL
60089
|
|
Applicant Contact |
Rekha Anand |
Correspondent |
Hogan Lovells US LLP |
1835 Market Street, 29th Floor |
Philadelphia,
PA
19103
|
|
Correspondent Contact |
Janice M. Hogan |
Regulation Number | 878.5040
|
Classification Product Code |
|
Date Received | 04/27/2017 |
Decision Date | 07/14/2017 |
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
|
|
|