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FDA 510(k) Application Details - K191068
Device Classification Name
More FDA Info for this Device
510(K) Number
K191068
Device Name
Powersculp laser lipolysis system
Applicant
Wuhan Lotuxs Technology Co., Ltd.
5 F, E2 Building, NO 999 Gaoxin Avenue, Future City
East lake High-Tech development Zone, Wu 430206 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
04/22/2019
Decision Date
07/17/2019
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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