Device Classification Name |
powered light based non-laser surgical instrument with thermal effect
|
510(k) Number |
K210119 |
Device Name |
IPL Hair Removal Device (Model: KCA423) |
Applicant |
Shenzhen Boyuan Intelligent Electronic Technology Co., Ltd |
RM202-203, Y2 Building, Chuangyi Park, Bantian Town, |
Long Gang District |
Shenzhen,
CN
|
|
Applicant Contact |
Cheryl Yang |
Correspondent |
SGS-CSTC Standards Technical Services Co., Ltd. |
198 Kezhu Road, SCIENTECH Park |
Guangzhou Economic & Technology Development |
Guangzhou,
CN
|
|
Correspondent Contact |
Iris Fung |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/19/2021 |
Decision Date | 05/21/2021 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|