FDA.reportPublic FDA data

510(k) K233962

Device
ReBorn (1050nm)
Applicant
Lightfective , Ltd.
510(k) number
K233962
Product code
PKT
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-16
Date received
2023-12-15
Regulation
878.5400
Classification name
Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Medical specialty
General, Plastic Surgery
Review panel
General, Plastic Surgery
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Tsvi Bahat
Address
2 Hatochen St. Caesarea IL 3079533 3079533

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K201731Diode Laser Body Sculpture SystemShanghai Apolo Medical Technology Co., Ltd.2020-09-10
K191068Powersculp laser lipolysis systemWuhan Lotuxs Technology Co., Ltd.2019-07-17
K180511Eon FRDominion Aesthetic Technologies, Inc.2019-06-12
K182741SculpSureCynosure2019-01-03
K171992SculpSureCynosure, Inc.2017-09-26
K171111SculpsureCynosure, Inc.2017-06-13