Device Classification Name |
powered light based non-laser surgical instrument with thermal effect
|
510(k) Number |
K211368 |
Device Name |
IPL Hair Remover, Model: G993, G996, G998 and G885 |
Applicant |
Shenzhen Mywin Technology Co., Ltd. |
2nd Floor, Building B, New Age gongrong Industrial Zone, |
No. 2, Shihuan Road, Shilong communit |
Shenzhen,
CN
|
|
Applicant Contact |
Meiyun Liu |
Correspondent |
Guangzhou KEDA Biological Tech Co., Ltd. |
6F, No.1 TianTai road, Science City, LuoGang District |
GuangZhou,
CN
|
|
Correspondent Contact |
Jet Li |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 05/04/2021 |
Decision Date | 10/04/2021 |
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
|
|
|