Device Classification Name |
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
|
510(k) Number |
K181896 |
Device Name |
LIPOcel |
Applicant |
Jeisys Medical, Inc. |
307, Daeryung Techno Town 8th, |
Gamasan-ro 96, Geumcheon-Gu |
Seoul,
KR
153-775
|
|
Applicant Contact |
Sugun Lee |
Correspondent |
Elexes Medical Consulting |
6494 Tralee Village Dr |
Dr Dublin,
CA
94568
|
|
Correspondent Contact |
Parul Chansoria |
Regulation Number | 878.4590
|
Classification Product Code |
|
Date Received | 07/16/2018 |
Decision Date | 10/18/2019 |
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
|
|
|