Device Classification Name |
massager, vacuum, radio frequency induced heat
|
510(k) Number |
K180709 |
Device Name |
truSculpt RF Device; truSculpt; truSculpt 3D |
Applicant |
Cutera, Inc. |
3240 Bayshore Blvd. |
Brisbane,
CA
94005
|
|
Applicant Contact |
Brad Renton |
Correspondent |
Cutera, Inc. |
3240 Bayshore Blvd. |
Brisbane,
CA
94005
|
|
Correspondent Contact |
Raymond Lee |
Regulation Number | 878.4400
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 03/19/2018 |
Decision Date | 06/06/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT03428243 NCT03433417
|
Reviewed by Third Party |
No
|
Combination Product |
No
|