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FDA 510(k) Application Details - K193609
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K193609
Device Name
Powered Laser Surgical Instrument
Applicant
Beijing Lead Beauty S & T Co., Ltd
202, No.5 workshop,
No.1 caida 3rd Road Nancai Shunyi District
Beijing 101300 CN
Other 510(k) Applications for this Company
Contact
Jiao Zhang
Other 510(k) Applications for this Contact
Regulation Number
878.4810
More FDA Info for this Regulation Number
Classification Product Code
GEX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/26/2019
Decision Date
03/20/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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