Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks

Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks

The purpose of this study is to evaluate histological results of the treatments with the TempSure Firm handpiece on the flanks performed in the CYN20-FIRM-LIPO study.

Up to 10 subjects will be enrolled at up to 3 study centers. Subjects will receive 2 biopsies, 1 biopsy in the treatment area (the flanks) and 1 biopsy outside of the treatment area to serve as a control.

Inclusion Criteria:

• Subject has completed their participation in the CYN20-FIRM-LIPO study.

Exclusion Criteria:

• The subject has not had any other treatment in the treatment area after their involvement in the CYN20-FIRM-LIPO study.
• The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.