FDA 510(k) Application Details - K191754

Device Classification Name Laser, Comb, Hair

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510(K) Number K191754
Device Name Laser, Comb, Hair
Applicant Kunshan Bella Optical technology Co., Ltd.
Plant 2, Kunshan Development Zone,
No. 218 Cheng Hu Road
Kunshan 215300 CN
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Contact Wu Xuefeng
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Regulation Number 890.5500

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Classification Product Code OAP
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Date Received 07/01/2019
Decision Date 11/22/2019
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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