The following data is part of a premarket notification filed by Ybk Investment Inc. with the FDA for A-tone Ipl System.
| Device ID | K131712 |
| 510k Number | K131712 |
| Device Name: | A-TONE IPL SYSTEM |
| Classification | Powered Light Based Non-laser Surgical Instrument With Thermal Effect |
| Applicant | YBK INVESTMENT INC. 1915 WHITE STAR DR. Diamond Bar, CA 91765 |
| Contact | Joyce Bang |
| Correspondent | Joyce Bang YBK INVESTMENT INC. 1915 WHITE STAR DR. Diamond Bar, CA 91765 |
| Product Code | ONF |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-11 |
| Decision Date | 2014-05-30 |
| Summary: | summary |