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FDA 510(k) Application Details - K211402
Device Classification Name
More FDA Info for this Device
510(K) Number
K211402
Device Name
Powersculp laser lipolysis system
Applicant
Lotuxs Medtech (Suzhou) Co., Ltd.
RM301, NW-06, Nanopolis Suzhou, 99 Jinji Lake Avenue,
Suzhou Industry
Suzhou 215123 CN
Other 510(k) Applications for this Company
Contact
Na Wu
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
PKT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/06/2021
Decision Date
07/30/2021
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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