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 |
00850062978003 | K161286 | 000 |