Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K213789 |
Device Name |
Intelligence LaserComb |
Applicant |
Yibin Yingtong Intelligent Technology Co.,Ltd. |
3F, Building 1, Area A, Intelligent Terminal Industrial Park |
Yibin Economic Development Zone |
Yibin,
CN
644000
|
|
Applicant Contact |
Pengcheng Pan |
Correspondent |
SGS-CSTC Standards Technical Services Co., Ltd. |
198 Kezhu Road, Scientech Park Guangzhou Economic & |
Technology Development District |
Guangzhou,
CN
510000
|
|
Correspondent Contact |
Iris Fung |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 12/06/2021 |
Decision Date | 06/24/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|