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FDA 510(k) Application Details - K200042
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K200042
Device Name
Powered Laser Surgical Instrument
Applicant
Beijing Superlaser Technology Co., Ltd.
No. 2 Zhongfu Street, E & T Industrial Zone
xihongmen Tower, Daxing District
Beijing 100076 CN
Other 510(k) Applications for this Company
Contact
Shi Shuang
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
01/08/2020
Decision Date
06/09/2020
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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