FDA 510(k) Application Details - K243030

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

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510(K) Number K243030
Device Name Light Based Over-The-Counter Hair Removal
Applicant Ulike Co., Ltd.
2, Myeongdong, 6-gil, Jung-gu, Seoul, Korea
Seoul KR
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Contact Blue Yang
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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 10/25/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee SU - General & Plastic Surgery
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K243030


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