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Medi LifeWhile you're deciding

While you're deciding

InMode and FDA Approval: What the Medical Device Clearance Means

When you research lifting procedures at a dermatology clinic, you often come across the phrase "FDA-approved." Yet there is not much detailed information on what this certification actually means or why it matters when choosing a procedure. InMode is an RF-based lifting medical device approved by the U.S. FDA (Food and Drug Administration). FDA approval means that a regulator has reviewed the device's safety and effectiveness on the basis of clinical data. That is why this certification can be one of the criteria when choosing treatment equipment.

Interior of Repic Clinic in Gangnam
Interior of Repic Clinic in Gangnam

Why InMode Received FDA Approval

InMode works by combining bipolar radiofrequency (Bipolar RF) energy with vacuum suction technology. RF energy is delivered to the deeper layers of the skin to stimulate collagen production, and at the same time heats fat cells to induce a tightening effect. During this process, a safety feedback system automatically checks the surface temperature of the skin 1,000 times per second. The FDA granted approval after reviewing the device's operating principle and clinical results, which is not just a marketing phrase but a fact formally recognized by a regulatory body.

The InMode FX and Forma series are widely used in cases that aim at partial fat reduction and improved skin firmness at the same time, particularly in the double chin, jawline and cheeks. Downtime is short, so a return to daily life is relatively quick, and it is sometimes run as a maintenance approach with repeated sessions.

How Is It Different from Shrink Universe?

A device often compared with InMode is Shrink Universe. Both devices aim at lifting, but their technologies are fundamentally different. InMode uses RF (radiofrequency) energy, while Shrink Universe uses high-intensity focused ultrasound (HIFU). HIFU works by passing ultrasound energy through the skin surface to form thermal coagulation points directly in the dermis and the SMAS layer (the fascia layer).

The choice depends on the nature of your concern. If improving sagging itself is the main goal, Shrink Universe, a HIFU device, may be considered. On the other hand, if fat distribution and sagging appear together, as with a double chin, RF-based InMode may be more suitable. For both procedures, it is hard to judge the result from a single session, and the number of sessions is generally adjusted at intervals of two to four weeks. Which is the better choice is best decided after your current skin condition has been checked with measurements.

Logo of the Repic Clinic dermatology practice in Gangnam.
Logo of the Repic Clinic dermatology practice in Gangnam.

The Diagnosis-Based Approach at Repic Clinic in Gangnam

At Repic Clinic in Gangnam (318 Gangnam-daero, Gangnam-gu, Seoul), a preliminary analysis is carried out before every lifting procedure, including InMode, using two diagnostic devices, Meta View and Mark-Vu. Meta View analyzes skin tone, pores, pigment distribution and surface texture in 3D, and Mark-Vu measures skin thickness, firmness, moisture and the location of sagging in numbers. Under the principle of not deciding on a procedure without diagnostic data, the direction of treatment may differ according to the diagnostic results even for the same symptoms.

This diagnostic process is also a way of applying the meaning of InMode's FDA approval in actual practice. While FDA approval reflects a regulatory review of a device's safety and effectiveness, how and on which skin condition to use that device is decided by diagnostic data. Repic Clinic in Gangnam states, as an internal clinic standard, that it does not recommend procedures that are not needed according to diagnosis.

Profile of Dr. Yong-Heon Ha, head physician at Repic Clinic in Gangnam, with his credentials. He is a full member of the Korean Society for Aesthetic and Plastic Laser Medicine and the Korean Society for Laser Dermatology and Trichology.
Profile of Dr. Yong-Heon Ha, head physician at Repic Clinic in Gangnam, with his credentials. He is a full member of the Korean Society for Aesthetic and Plastic Laser Medicine and the Korean Society for Laser Dermatology and Trichology.

What to Check Before the Procedure

There are a few things to check beforehand when considering InMode. First, it is important to understand the skin condition and fat distribution of the treatment area in advance, because the depth and intensity at which RF energy is delivered need to be adjusted for skin thickness. The procedure may be limited if a contraindication applies, such as a metal implant or pacemaker, and this should generally be confirmed during the consultation. After the procedure, temporary redness or swelling may appear, which is a tissue reaction to RF energy and generally eases over time.

  • Pre-procedure assessment: checking skin thickness, firmness and fat distribution in numbers is recommended
  • Contraindications: people with a metal implant or pacemaker should generally let the clinic know at the consultation
  • Post-procedure reaction: temporary redness and swelling are possible, and individual differences exist
  • Number of sessions: generally adjusted at two- to four-week intervals; results should not be judged from a single session

InMode's FDA approval can be a starting point for choosing a device, but the final decision about a procedure should be based on your own skin condition and goals. At Repic Clinic in Gangnam, you can receive specific guidance through a consultation that uses the dual diagnostic devices.

Related official information

You can find more details on the official website.

Repic Clinic official website →

※ This content is for general information only and does not replace a medical diagnosis or treatment. Please consult a medical professional before any procedure. Results, downtime and side effects vary from person to person.

Dr. Yong-Heon HaShrink Universe