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 |