The following data is part of a premarket notification filed by Beijing Adss Development Co., Ltd with the FDA for Diode Laser Therapy Machine.
| Device ID | K161692 |
| 510k Number | K161692 |
| Device Name: | Diode Laser Therapy Machine |
| Classification | Powered Laser Surgical Instrument |
| Applicant | BEIJING ADSS DEVELOPMENT CO., LTD F6, XIANDO 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 | 2016-06-20 |
| Decision Date | 2016-11-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970453270098 | K161692 | 000 |
| 06970453270081 | K161692 | 000 |
| 06970453270074 | K161692 | 000 |
| 06970453270067 | K161692 | 000 |