Histologic Evaluation of Tissue Following Lutronic System Exposure

Summary

Enrollment of up to 25 subjects; subjects enrolled may be greater than subjects receiving test spot exposure visits. No pre-treatment medication prior to test spot exposure. Up to 6 tattoo points will be applied to each side of the abdomen immediately before or after test spot exposures to map and locate exposed spots on the excised pannis. Tattoos in the area to be resected will be placed to outline the test spot exposure areas. Photographs of exposed sites may be taken at investigator's discretion.

Conditions

• Abdominoplasty

Interventions

DEVICE

Genius

The Infini Radiofrequency System (K121481) is the predicate device. It is a minimally invasive radiofrequency device that employs a bipolar microneedle electrode system indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The Genius system is substantially equivalent to the Infini device with a digitally controlled direct drive mechanism for needle insertion and an improved needle design for easier needle insertion. The active tip of the Genius system is the substantially equivalent to the Infini device. The handpiece of the Genius system has also been redesigned to be lighter and more ergonomic.

DEVICE

eC02

The eCO2 Laser System (K091115) is indicated for use in dermatological procedures requiring ablation (removal), resurfacing and coagulation of soft tissue. Additionally, the 120 micron and 300 micron spot sizes are used in the treatment of wrinkles; rhytides, furrows, fine lines, textural irregularities, pigmented lesions and vascular dyschromia. The fractional 90 degree BellaV handpiece is intended to provide fractional CO2 treatment of skin and is not yet cleared.

DEVICE

PicoPlus

The PICOPLUS Laser System (K173700) is indicated for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery as follows:

DEVICE

LaseMD

The LaseMD Laser System (K171009) is a 1927 factional thulium laser indicated for use in dermatological procedures requiring the coagulation of soft tissue, treatment of actinic keratosis, and treatment of benign pigmented lesions such as, but not limited to lentigos (age spots), solar lentigos (sun spots) and ephiledes (freckles). The cleared LaseMD system is a 5W system.

DEVICE

LaseMD Flex

There are two new versions of the LaseMD system to be used in this study that are uncleared and investigational use only. The only change from the cleared system to the one of the LaseMD systems to be used in this study is that the watts have been increased to 20W and a new tip configuration with a larger 250+ um spot size. The other LaseMD system to be used in this study is the LaseMD FLEX. It also has 20W with larger spot size, a modified flat-top beam profile (as opposed to a Gaussian beam profile) and a faster scan rate. All other technical specifications remain the same as the cleared device.

Sponsors & Collaborators

• LUTRONIC Corporation

  lead INDUSTRY

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2018-10-02

Primary Completion

2018-10-31

Completion

2020-03-31

FDA Device

Yes

Countries

• United States

Study Locations