FDA 510(k) Application Details - K243036

Device Classification Name Light Based Over-The-Counter Hair Removal

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510(K) Number K243036
Device Name Light Based Over-The-Counter Hair Removal
Applicant Bestway Plastic And Metal Products Ltd.
Room 701, Building 2, No.1 Chuangye San Road, Mapu Ao,
Fenggang Town, Dongguan City
Shenzhen 523682 CN
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Contact Jonah Ci
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Regulation Number 878.4810

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Classification Product Code OHT
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Date Received 09/27/2024
Decision Date 06/15/2025
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K243036


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