The Lightfective ReBorn System is intended for non-invasive lipolysis of the flanks in individuals with a Body Mass Index (BMI) of 30 or less. The device is intended to affect the appearance of visible fat bulges in the flanks.
Body countering and fat reduction treatment are considered to be one of the most popular aesthetic procedures. The Lightfective' ReBorn LED System provides non-invasive fat reduction treatment. The primary efficacy objective is to demonstrate fat reduction in the treated area after treatment with the ReBorn LED system. study population, Healthy subjects who seek for fat reduction treatments in the flanks area. Each subject will undergo 2 treatment visits (one month apart) and follow-up visits.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
107
Fat reduction treatments with the ReBorn LED System visit - include the treatment procedure
Tennessee Clinical Research Center
Tennessee City, Tennessee, United States
Herzelia Medical Center - Tal Nachliely clinic
Kiryat Bialik, Israel
rabin medical center - campus Hasharon
Petah Tikva, Israel
Fat reduction
to demonstrate fat reduction in the treated area after treatment with the ReBorn LED system.
Time frame: 20 weeks
Blinded reviewers evaluation
subject's pre and post-treatment photographs will be presented in randomized order to blinded reviewers for evaluation. Subject is considered "success" if at least two out of the three evaluators correctly identify photographs order.
Time frame: 20 weeks
safety evaluation
The safety of the ReBorn LED System will be demonstrated by serious adverse event during the study.
Time frame: 20 weeks
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