Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K192516 |
Device Name |
Diode Laser 808nm |
Applicant |
Beijing Superlaser Technology Co., Ltd. |
No. 2 Zhongfu Street, Economic and Technological Industrial |
Zone |
Xihongmen Town, Daxing District, Beijing,
CN
100076
|
|
Applicant Contact |
Shi Shuang |
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 | 12/10/2019 |
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
|
|
|