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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stimulator, Transcutaneous Electrical, Aesthetic Purposes
510(k) Number K214100
Device Name Luminice
Applicant
Premier North America, Inc.
3301 SW 42nd St.
Fort Lauderdale,  FL  33312
Applicant Contact Ellis Tamari
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 903, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number882.5890
Classification Product Code
NFO  
Date Received12/29/2021
Decision Date 02/24/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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