Device Classification Name |
powered laser surgical instrument
|
510(k) Number |
K220268 |
Device Name |
Picosecond Laser System (Model PS10-A and PS10-B) |
Applicant |
Beijing ADSS Development Co., Ltd. |
F2,Building 1,Jinyuan Road 36 Daxing Economic Development |
Zone |
Beijing,
CN
102628
|
|
Applicant Contact |
Song Ying |
Correspondent |
Shanghai Truthful Information Technology Co., Ltd. |
RM.1801,No.161,East Lujiazui Rd.,Pudong |
Shanghai,
CN
200120
|
|
Correspondent Contact |
Boyle Wang |
Regulation Number | 878.4810
|
Classification Product Code |
|
Date Received | 01/31/2022 |
Decision Date | 08/23/2022 |
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
|
|
|