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FDA 510(k) Application Details - K212734
Device Classification Name
Powered Laser Surgical Instrument
More FDA Info for this Device
510(K) Number
K212734
Device Name
Powered Laser Surgical Instrument
Applicant
TRIANGEL RSD LIMITED
Center Building 4, C Unit 324, #3088, Lekai North Street,
Power Valley Technology
Baoding CN
Other 510(k) Applications for this Company
Contact
Zhao Fengdan
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
08/30/2021
Decision Date
06/06/2023
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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