The following data is part of a premarket notification filed by Premier North America Inc. with the FDA for Eneo Totale (model: Eneot947).
| Device ID | K213841 |
| 510k Number | K213841 |
| Device Name: | ENEO TOTALE (Model: ENEOT947) |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Premier North America Inc. 3301 SW 42nd Street Ft Lauderdale, FL 33312 |
| Contact | Ellis Tamari |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, CN 201613 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-09 |
| Decision Date | 2022-01-06 |