The following data is part of a premarket notification filed by Meta Systems Co., Ltd. with the FDA for Ems-200.
| Device ID | K153285 |
| 510k Number | K153285 |
| Device Name: | EMS-200 |
| Classification | Handpiece, Direct Drive, Ac-powered |
| Applicant | META SYSTEMS CO., LTD. RM 607, BYUCKSAN DIGITAL VALLEY 6, 219 GASANDIGITAL 1-RO, GEUMCHEON-GU Seoul, KP 08501 |
| Contact | Ray Jeon |
| Correspondent | Yolanda Smith SMITH ASSOCIATES 1468 HARWELL AVE Crofton, MD 21114 |
| Product Code | EKX |
| Subsequent Product Code | EKR |
| Subsequent Product Code | LQY |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-12 |
| Decision Date | 2016-08-12 |
| Summary: | summary |