Device Classification Name |
powered light based non-laser surgical instrument with thermal effect
|
510(k) Number |
K200746 |
Device Name |
IPL Treatment Systems |
Applicant |
Shanghai Apolo Medical Technology Co., Ltd. |
4F, Building A, No.388, Yindu Road, Xuhui District |
Shanghai,
CN
200231
|
|
Applicant Contact |
Felix Li |
Correspondent |
Shanghai Apolo Medical Technology Co., Ltd. |
4F, Building A, No.388, Yindu Road, Xuhui District |
Shanghai,
CN
200231
|
|
Correspondent Contact |
Felix Li |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 03/23/2020 |
Decision Date | 05/15/2020 |
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
|
|
|