FDA 510(k) Application Details - K232356

Device Classification Name Laser, Comb, Hair

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510(K) Number K232356
Device Name Laser, Comb, Hair
Applicant Hubei YJT Technology Co.,Ltd
Room1-4 ,8F,Block7,Guannan Fuxing Pharmaceutical Park,No.62
Optical Valley Ave
Wuhan 430000 CN
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Contact Jiali Xie
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 08/07/2023
Decision Date 10/24/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
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 K232356


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