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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Light Based Over The Counter Wrinkle Reduction
510(k) Number K181659
Device Name Avologi ENEO
Applicant
Premier North America, Inc.
3301 SW 42nd St.
Fort Lauderdale,  FL  33312
Applicant Contact Yaniv Applicant
Correspondent
Shanghai CV Technology Co., Ltd.
Rm. 903 Of Dongbao Bldg.
# 19 Dongbao Rd., Songjiang Area
Shanghai,  CN 201613
Correspondent Contact Doris Dong
Regulation Number878.4810
Classification Product Code
OHS  
Date Received06/25/2018
Decision Date 07/26/2018
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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