Device Classification Name |
over-the-counter powered light based laser for acne
|
510(k) Number |
K162371 |
Device Name |
Pulsaderm ACE-All Blue |
Applicant |
Nutra Luxe MD, LLC |
12801 Commonwealth Dr. Unit 5 |
Fort Meyers,
FL
33913
|
|
Applicant Contact |
Gloria Avendano |
Correspondent |
Nutra Luxe MD, LLC |
12801 Commonwealth Dr. Unit 5 |
Fort Meyers,
FL
33913
|
|
Correspondent Contact |
Gloria Avendano |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 08/24/2016 |
Decision Date | 12/15/2016 |
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
|