The following data is part of a premarket notification filed by Premier North America Inc. with the FDA for Luminice.
| Device ID | K214100 |
| 510k Number | K214100 |
| Device Name: | Luminice |
| Classification | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| Applicant | Premier North America Inc. 3301 SW 42nd Street Fort Lauderdale, FL 33312 -6828 |
| Contact | Ellis Tamari |
| Correspondent | Doris Dong Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, CN 201613 |
| Product Code | NFO |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-29 |
| Decision Date | 2022-02-24 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LUMINICE 85081396 4013704 Live/Registered |
Manitowoc Foodservice Companies, LLC 2010-07-09 |
![]() LUMINICE 79265821 not registered Live/Pending |
Bora Creations S.L. 2019-05-03 |