Device Classification Name |
Laser, Comb, Hair
|
510(k) Number |
K192552 |
Device Name |
Irradiation Cosmetic Device |
Applicant |
Chongqing Peninsula Medical Technology Co., Ltd. |
No.2-4, 2F BLK1, Biological and Biochemical Park, |
70-1 & 70-2# Ke Yuan 4 RD |
Jiulongpo District,
CN
404100
|
|
Applicant Contact |
Zhang Sudi |
Correspondent |
Guangzhou GLOMED Biological Technology Co., Ltd. |
2231, Building 1, Rui Feng Center, Kaichuang Road, |
Huangpu District |
Guangzhou,
CN
51006
|
|
Correspondent Contact |
Cassie Lee |
Regulation Number | 890.5500
|
Classification Product Code |
|
Date Received | 09/17/2019 |
Decision Date | 04/17/2020 |
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
|
|
|