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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over-The-Counter Powered Light Based Laser For Acne
510(k) Number K232656
Device Name BLU TOTALE (Model: ENEOB852)
Applicant
Premier North America, Inc.
3301 SW 42nd St.
Fort Lauderdale,  FL  33312 -6828
Applicant Contact Ellis Tamari
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 602, #19 Dongbao Rd., Songjiang Area,
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number878.4810
Classification Product Code
OLP  
Date Received08/31/2023
Decision Date 11/14/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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