The following data is part of a premarket notification filed by Beijing Adss Development Co., Ltd. with the FDA for Picosecond Laser System (model Ps10-a And Ps10-b).
| Device ID | K220268 |
| 510k Number | K220268 |
| Device Name: | Picosecond Laser System (Model PS10-A And PS10-B) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Beijing ADSS Development Co., Ltd. F2,Building 1,Jinyuan Road 36 Daxing Economic Development Zone Beijing, CN 102628 |
| Contact | Song Ying |
| Correspondent | Boyle Wang Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161,East Lujiazui Rd.,Pudong Shanghai, CN 200120 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-31 |
| Decision Date | 2022-08-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970453270166 | K220268 | 000 |
| 06970453270159 | K220268 | 000 |