Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K173436 |
Device Name |
Luma Light System |
Applicant |
Luma Therapeutics |
10 Rollins Rd |
Suite 120 |
Millbrae,
CA
94030
|
|
Applicant Contact |
Tiffini Wittwer |
Correspondent |
Luma Therapeutics |
10 Rollins Rd |
Suite 120 |
Millbrae,
CA
94030
|
|
Correspondent Contact |
Tiffini Wittwer |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 11/03/2017 |
Decision Date | 01/30/2018 |
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
|