The following data is part of a premarket notification filed by Beijing Kes Biology Technology Co., Ltd. with the FDA for Intense Pulsed Light (ipl) Systems.
| Device ID | K122995 |
| 510k Number | K122995 |
| Device Name: | INTENSE PULSED LIGHT (IPL) SYSTEMS |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. P.O. BOX 237-023 Shanghai, CN 200237 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-26 |
| Decision Date | 2013-01-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971513121022 | K122995 | 000 |
| 06971513121015 | K122995 | 000 |