The following data is part of a premarket notification filed by Beijing Starlight Science & Technology Development with the FDA for Ipl Therapy System.
| Device ID | K101901 |
| 510k Number | K101901 |
| Device Name: | IPL THERAPY SYSTEM |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPMENT SUITE 5D NO. 19 LANE 999 ZHONGSHAN NO 2 ROAD(S) Shanghai Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING STARLIGHT SCIENCE & TECHNOLOGY DEVELOPMENT SUITE 5D NO. 19 LANE 999 ZHONGSHAN NO 2 ROAD(S) Shanghai Shanghai, CN 200030 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-07-08 |
| Decision Date | 2011-03-08 |
| Summary: | summary |