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How to Check InMode FDA-Approved Medical Device Certification

InMode is a radiofrequency (RF) lifting device that Repic Clinic in Gangnam describes as FDA-approved equipment. However, FDA approval is a designation based on the device and its approved use, and it is not a statement that promises an individual's procedure results. The FDA-approved medical device certification of InMode is easiest to sort out by checking it in the five steps below.

A scene showing the interior facilities of Repic Clinic in Gangnam.
A scene showing the interior facilities of Repic Clinic in Gangnam.

What the FDA Approval of InMode Covers

According to Repic Clinic in Gangnam materials, InMode delivers RF energy up to the fascia (SMAS) layer, aiming for fat reduction, collagen production and tightening at the same time. It is used for improving the double chin, jawline and cheeks, and the device in use is InMode FX/Forma. This device is introduced as one that checks the epidermal temperature 1,000 times per second.

Whether it has Korean KFDA (Ministry of Food and Drug Safety) approval is not separately stated in the materials provided. This is an item to confirm directly at the consultation.

Five Steps to Check Before the Procedure

  1. STEP 1. Confirm the device model name
    FDA approval is distinguished by model and indication. First ask whether the device used for the procedure is InMode FX/Forma.
  2. STEP 2. Confirm the scope of approval and authorization
    At the consultation, ask about the content of the FDA approval, whether it is authorized in Korea, and whether the treatment area falls under the approved use.
  3. STEP 3. Diagnose your skin condition
    Repic Clinic in Gangnam has Metaview, a 3D skin diagnostic device, and Markview, a skin analysis device. It is recommended to measure skin condition through diagnosis before deciding on the procedure.
  4. STEP 4. Compare fat distribution and degree of sagging
    InMode uses bipolar RF and vacuum suction to address localized fat reduction and firmness improvement together. If sagging is your main concern, you can compare it with Shrink, which uses high-intensity focused ultrasound (HIFU).
  5. STEP 5. Confirm the number of sessions, interval and precautions
    It is hard to judge the effect from one session, and the number of sessions is usually adjusted at 2-to-4-week intervals. Please be guided at the consultation on the reactions that may appear after the procedure and on daily-life precautions, along with any medication you take and your medical history.

Checking Summary at a Glance

StepWhat to checkHow to check
1Device modelAsk whether it is InMode FX/Forma
2Scope of approval and authorizationAsk about the FDA approval content and KFDA authorization
3Skin condition3D diagnosis, skin analysis
4Procedure choiceCompare fat distribution and degree of sagging
5Sessions and precautionsAdjust at 2-4 week intervals, individual consultation

Following this order lets you decide on a procedure by looking at device information together with your own skin condition, rather than relying only on the phrase "FDA-approved medical device certification" for InMode.

Frequently Asked Questions

If InMode is FDA-approved equipment, will the results be the same for everyone?

No. FDA approval is a standard for the device and its approved use, and procedure results vary from person to person depending on skin condition and fat distribution. It is better to first confirm through diagnosis and consultation whether it suits you.

How do I choose between InMode and Shrink?

InMode addresses localized fat reduction and firmness improvement together with bipolar RF and vacuum suction, and it is mentioned as a possible candidate when both under-chin fat and sagging are concerns. Shrink stimulates the dermis and SMAS layer with HIFU, so it is used mainly for improving sagging. For both procedures, deciding after a diagnosis is recommended.

How many InMode sessions are needed, and at what interval?

It is hard to judge the effect from one session, so the number of sessions is usually adjusted at 2-to-4-week intervals. Downtime is described as short, but the specific number of sessions and interval are decided at the consultation.

Source: equipment and service materials provided by Repic Clinic in Gangnam. Location: 318 Gangnam-daero, Gangnam-gu, Seoul, basement level 1 and 2nd floor.

Organization logo of the dermatology clinic, Repic Clinic in Gangnam.
Organization logo of the dermatology clinic, Repic Clinic in Gangnam.

This information is medical information provided by Repic Clinic (basement level 1 and 2nd floor, TOWER837, 318 Gangnam-daero, Gangnam-gu) and complies with the medical advertising standards under Article 56 of the Korean Medical Service Act. Procedure effects may differ from person to person, so please obtain an accurate diagnosis and consultation by visiting the clinic.

Related Official Information

You can find more details about the above 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.

InModeFDA-approved deviceRF lifting