Device Classification Name |
Powered Laser Surgical Instrument
|
510(k) Number |
K160488 |
Device Name |
Cutera enlighten III Laser System |
Applicant |
Cutera, Inc. |
3240 Bayshore Blvd. |
Brisbane,
CA
94005
|
|
Applicant Contact |
Bradley Renton |
Correspondent |
Cutera, Inc. |
3240 Bayshore Blvd. |
Brisbane,
CA
94005
|
|
Correspondent Contact |
Bradley Renton |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 02/22/2016 |
Decision Date | 10/28/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Clinical Trials |
NCT02635880
|
Reviewed by Third Party |
No
|
Combination Product |
No
|