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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 K230490
Device Name PMD Clean Acne, Model: 4004-CABLUE-NA, 4004-GREY-NA, 4004-YELLOW-NA, 4004-PSTO-NA, 4004-LPUR-NA, 4004-CABLUE-NA-INT, 4004-GREY-INT, 4004-YELLOW-INT, 4004-PSTO-INT, 4004-LPUR-INT
Applicant
Dongguan Hunter Electronic Technology Co., Ltd.
Room 301, Building 6, 74 Qiaodong Road
Tangxia Town
Dongguan City,  CN 523728
Applicant Contact Hunter Ye
Correspondent
Feiying Drug & Medical Consulting Technical Service Group
Rn 2401 Zhenye International Business Center
No. 3101-90, Qianhai Road
Shenzhen,  CN 518052
Correspondent Contact Tracy Che
Regulation Number878.4810
Classification Product Code
OLP  
Date Received02/23/2023
Decision Date 10/27/2023
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
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