The following data is part of a premarket notification filed by Beijing Adss Development Co., Ltd with the FDA for Co2 Laser Therapy Machine.
| Device ID | K161925 |
| 510k Number | K161925 |
| Device Name: | CO2 Laser Therapy Machine |
| Classification | Powered Laser Surgical Instrument |
| Applicant | Beijing ADSS Development Co., Ltd F6, Xiandao Bldg., Jinyuan Rd. 36 Daxing Economic Development Zone Beijing, CN 102628 |
| Contact | Gao Yurong |
| Correspondent | Ray Wang Beijing Believe Technology Service Co., Ltd. 5-1206, Build 332, DaFangJu, No.25 BanBiDian Rd., Liyuan Town, Tongzhou District, Beijing, CN 101121 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-13 |
| Decision Date | 2016-10-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970453270128 | K161925 | 000 |
| 06970453270111 | K161925 | 000 |
| 06970453270104 | K161925 | 000 |