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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 K210545
Device Name Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine, Infrared Red blue LED light heat beauty machine
Applicant
Marci Beauty, Inc.
4290 Cameron St.
Unit 7
Las Vegas,  NV  89103
Applicant Contact Shaul Rappaport
Correspondent
Wenzhou Cytech Information Service Co., Ltd.
Rm.302, Bldg. 3, Hangqian Mansion, Hanqian St.,
Lucheng District
Wenzhou,  CN 325000
Correspondent Contact Helen Nan
Regulation Number878.4810
Classification Product Code
OLP  
Subsequent Product Code
OHS  
Date Received02/25/2021
Decision Date 05/20/2022
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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