Device Classification Name |
powered light based non-laser surgical instrument with thermal effect
|
510(k) Number |
K192521 |
Device Name |
Intense Pulsed Light Treatment System |
Applicant |
Shangdong Huamei Technology Co., Ltd. |
No. 588, Changning Street, High-tech District |
Weifang,
CN
261205
|
|
Applicant Contact |
Xu QingHua |
Correspondent |
Beijing Believe-Med Technology Service Co., Ltd. |
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd. |
FangShan District |
Beijing,
CN
102401
|
|
Correspondent Contact |
Ray Wang |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 09/13/2019 |
Decision Date | 12/06/2019 |
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
|
|
|