Device Classification Name |
Light, Ultraviolet, Dermatological
|
510(k) Number |
K181805 |
Device Name |
UV Phototherapy |
Applicant |
Xuzhou Kernel Medical Equipment Co., LTD. |
Kernel Mansion, Economic Development District |
Xuzhou,
CN
221004
|
|
Applicant Contact |
Jing Wang |
Correspondent |
Mid-Link Consulting Co., Ltd |
P.O. Box 120-119 |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Diana Hong |
Regulation Number | 878.4630
|
Classification Product Code |
|
Date Received | 07/06/2018 |
Decision Date | 01/11/2019 |
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
|
|
|