FDA 510(k) Application Details - K230134

Device Classification Name Laser, Comb, Hair

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510(K) Number K230134
Device Name Laser, Comb, Hair
Applicant Hubei YJT Technology Co.,Ltd
Room 1-8,8F, Building 7, Guannan Fuxing Pharmacel Park,
No.58, Optics Valley Avenue
Wuhan 43000 CN
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Contact Hua Xinag
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 01/17/2023
Decision Date 05/23/2023
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 K230134


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