SculpSure é um laser diodo, o primeiro do mundo aprovado pela FDA, para tratamentos da lipólise não invasiva que permite eliminar a gordura localizada e persistente nos flancos, abdómen, costas e coxas internas e externas, em sessões de 25 minutos por área. How did SculpSure get approval? Cynosure, the manufacturers of SculpSure, worked with the FDA through clinical trials to make sure the treatment meets rigorous scientific standards and is very safe. The FDA is independent and uses its own scientists, chemists and medical professionals to assess the efficacy and safety of all treatments it approves. SculpSure® — FDA Approved Fat Reduction Treatment Even with diet and exercise, most people have stubborn pockets of fat that seem impossible to lose. SculpSure’s body contouring technology is able to target and permanently destroy these fat cells without surgery or any downtime.
Primeiro equipamento do mundo a obter FDA para laser lipólise não-invasiva. O SculpSure usa a tecnologia do laser para romper as células adiposas, situadas abaixo da pele, de forma segura, sem cirurgia e sem downtime, levando a uma redução permanente no número de células de gordura. Hologic, Inc., Nasdaq: HOLX anunciou que a Administração de Alimentos e Medicamentos dos Estados Unidos US Food and Drug Administration FDA concedeu a aprovação ao seu equipamento SculpSure para tratar a gordura localizada na papada ou duplo-queixo, mais conhecida como papo ou. SculpSure’s non-invasive fat reduction technology has been clinically proven to reduce the number of fat cells in the treated area in just 25 minutes. Other fat freezing technologies remove heat from the fat cells, freezing and crystalizing them, which also damages their structural integrity. É o primeiro e único laser aprovado pela FDA para o tratamento de gordura localizada. Trata-se de um laser de Diodo, com comprimento de onda de 1060nm, com grande afinidade para as células do tecido adiposo, respeitando as camadas mais superficiais da pele, o que confere ao tratamento um excelente perfil de segurança. SculpSure® is a new, noninvasive, FDA-approved treatment that reduces fat in tough-to-lose areas, like the abdomen, thighs, flanks love handles and under the chin. The SculpSure® system uses a controlled light-based laser technology to get rid of unwanted fat deposits.
Date Received: 02/02/2015: Decision Date: 05/15/2015: Decision: substantially equivalent SESE Regulation Medical Specialty: General & Plastic Surgery. DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 15, 2015 Cynosure, Inc. Kevin O' Connell Director Regulatory Affairs 5 Carlisle Road Westford, Massachusetts 01886 Re: K150230 Trade/Device Name: SculpSure.
It provides an excellent complement to fat loss routines, along with healthy eating habits and exercise. Unlike other non-invasive fat reduction treatments, no recovery time is necessary after a SculpSure session. SculpSure Is FDA-Approved. A toned and trim body is achievable with the FDA-approved technology of SculpSure. Dr. 01/08/2019 · In a press release announcing the FDA’s approval of SculpSure for use in this area, a company representative stated that the device has been cleared for use on patients with a higher BMI than what it’s allowed with other noninvasive fat reduction devices. 16/06/2017 · Kidding. Or, you could make an appointment with your dermatologist for SculpSure, a non-invasive treatment used to eliminate excess fat cells, which was just approved by the FDA to treat the back and inner and outer thighs. SculpSure is the world’s first FDA-cleared laser device for non-invasive lipolysis of the abdomen, flanks, back, inner thighs, outer thighs and submental area. WarmSculpting Profile. Our Submental applicator design is perfect for providing precise and effective treatments.
SculpSure represents the latest technology in non-invasive body contouring. Cleared by the FDA in 2016, SculpSure has rivaled CoolSculpting in the non-surgical fat reduction industry in several ways: SculpSure can treat up to 4 different areas at one time, whereas CoolSculpting can only do one at a time. WarmSculpting with SculpSure is a non-invasive, 25 minute body contouring treatment that is designed to reduce stubborn fat in the abdomen, back, flanks, thighs and under the chin area. Achieving a slimmer, more sculpted appearance is possible with the help of SculpSure. Frequently Asked Questions: What is SculpSure? The first FDA-approved, non-invasive laser treatment used to breakdown stubborn body fat on the sides and stomach. The light-based laser procedure injures the fat cells in the subcutaneous layer of the skin.
Sculpsure Approved by FDA for Thighs and Back Our specialists at PSS are pleased to announce that the FDA, the U.S. Food and Drug Administration has given SculpSure 510K clearance to treat unwanted areas of fat in a patient’s inner and outer thighs and back. SculpSure is a non-invasive, 25 minute body contouring treatment that is designed to reduce stubborn fat in the abdomen and flanks. Sculpsure es el primer tratamiento láser aprobado por la FDA Agencia Federal de Administración de Comida y Medicina de Estados Unidos, y es una tecnología creada para personas que buscan deshacerse de la grasa acumulada en áreas específicas, como la barriga y los costados. SculpSure is the world’s first FDA-cleared laser device for non-invasive lipolysis of the abdomen, flanks, back, inner thighs, outer thighs and submental area. WarmSculpting Profile Treatment. Our Submental applicator design is perfect for providing precise and effective treatments resulting in a slimmer appearance of the chin and neck. SculpSure is FDA-cleared to reduce stubborn fat in the belly, love handles, back, thighs, and now under the chin. Is SculpSure right for me? SculpSure is ideal for people with trouble spots, particularly those that seem resistant to diet and exercise. How many.
SculpSure is the world’s first FDA-cleared laser treatment for non-invasive lipolysis of the abdomen, flanks, back, inner thighs, outer thighs and the submental area. It’s designed to safely and effectively eliminate unwanted fat cells. Foi desenvolvido um laser não-invasivo aprovado pela FDA para a lipólise específica do abdómen e dos flancos. Trata-se de uma tecnologia mãos-livres baseada em luz controlada, que se diferencia pelo comprimento de onda 1060nm que actua sem recurso a cirurgia ou tempo de inactividade. 14/06/2017 · SculpSure: New FDA approved Treatment Areas June 14, 2017 · Rylan · Posted in Latest Posts · With Father’s Day fast approaching we are pleased to announce SculpSure has received 510K clearance to market from the U.S. Food and Drug Administration FDA for the treatment of the back, inner thighs, and outer thighs.
SculpSure™ is the very first FDA cleared, non-invasive laser platform for permanent fat reduction. SculpSure™ works by heating up the fat cells above a threshold temperature to which they are no longer viable. The body then clears away the damaged fat cells on its own. SculpSure is an FDA-cleared device to reduce fat under the chin. Contact a provider to find out if WarmSculpting with SculpSure is right for you. Play. How WarmSculpting with SculpSure works Target Targeted laser energy heats fat cells under the skin without affecting the skin’s surface.
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