The following data is part of a premarket notification filed by Beijing Sincoheren S&t Development Co Ltd with the FDA for Ipl Therapy System.
| Device ID | K123435 |
| 510k Number | K123435 |
| Device Name: | IPL THERAPY SYSTEM |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD 7TH FLOOR 982 CONGYUN ROAD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Contact | Mike Gu |
| Correspondent | Mike Gu BEIJING SINCOHEREN S&T DEVELOPMENT CO LTD 7TH FLOOR 982 CONGYUN ROAD, BAIYUN DISTRICT Guangzhou, Guangdong, CN 510420 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-07 |
| Decision Date | 2013-02-11 |
| Summary: | summary |