FDA 510(k) Application Details - K222477

Device Classification Name Laser, Comb, Hair

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510(K) Number K222477
Device Name Laser, Comb, Hair
Applicant Dongguan Lescolton Medical Equipment Co., Ltd
402, Building 1, #3, Xinxing 3rd Road, jiaoshe, Dongkeng
Town
Dongguan 523443 CN
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Contact Qixiang Liu
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 08/16/2022
Decision Date 11/18/2022
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 K222477


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