The following data is part of a premarket notification filed by Premier North America Inc. with the FDA for Avologi Eneo.
| Device ID | K181659 |
| 510k Number | K181659 |
| Device Name: | Avologi ENEO |
| Classification | Light Based Over The Counter Wrinkle Reduction |
| Applicant | Premier North America Inc. 3301 SW 42nd St Fort Lauderdale, FL 33312 -6828 |
| Contact | Yaniv Applicant |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd. Room 903 Of Dongbao Building No. 19 Dongbao Road, Songjiang Area Shanghai, CN 201613 |
| Product Code | OHS |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-25 |
| Decision Date | 2018-07-26 |
| Summary: | summary |