The following data is part of a premarket notification filed by Beijing Adss Development Co., Ltd with the FDA for Ipl Therapy Machine.
| Device ID | K161286 |
| 510k Number | K161286 |
| Device Name: | IPL Therapy Machine |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | BEIJING ADSS DEVELOPMENT CO., LTD F6, XIANDAO BLDG.,JINYUAN RD. 36, DAXING ECONOMIC DAXING ECONOMIC DEVELOPMENT ZONE Beijing, CN 102628 |
| Contact | Yurong Gao |
| Correspondent | Ray Wang BEIJING BELIEVE TECHNOLOGY SERVICES CO., LTD. 5-1206, BUILD 332, DAFANGJU, NO.25 BANBIDIAN RD. Liyuan Town, Tongzhou District, Beijing, CN 101121 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-09 |
| Decision Date | 2016-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06970453270005 | K161286 | 000 |
| 06970453270043 | K161286 | 000 |