Aesthetic dermatology in Roppongi.

This treatment is a self-paid procedure performed using a medical device that has not received approval under Japan’s Pharmaceuticals and Medical Devices Act. The following information is provided in accordance with the MHLW Medical Advertising Guidelines.

1. 1. Unapproved medical device

   The "ONDA PRO" device used in this treatment has not received approval under Japan’s Pharmaceuticals and Medical Devices Act.

2. 2. Acquisition route

   Our clinic obtains this device, made by "DEKA M.E.L.A. S.r.l." (Italy), via a domestic distributor, and uses it under the responsibility of the attending physician.

3. 3. Domestically approved equivalent devices

   There is no domestically approved medical device identical to this device using Coolwaves® (microwave) technology.

   Domestically approved medical devices intended for similar effects include: Radiofrequency (RF) devices, High-Intensity Focused Ultrasound (HIFU) devices.

4. 4. Safety information from other countries

   In the United States, an equivalent model of this device has received FDA 510(k) clearance for indications such as temporary relief of pain and muscle spasm and temporary improvement of local blood circulation, and in Europe the manufacturer applies CE marking to the device as a medical device. However, the aesthetic (skin-tightening and localized fat reduction) use performed at our clinic is not an approved indication in major Western countries. For this intended use, safety information is limited, and significant risks may not yet have been identified.

※ The device used in this treatment is not approved in Japan. In the event of any health damage, it is not covered by Japan's Adverse Drug Reaction Relief System or any other national relief program.

This treatment is a self-paid procedure performed using a medical device that has not received approval under Japan’s Pharmaceuticals and Medical Devices Act. The following information is provided in accordance with the MHLW Medical Advertising Guidelines.

1. 1. Unapproved medical device

   The "Alltite" device used in this treatment has not received approval under Japan’s Pharmaceuticals and Medical Devices Act.

2. 2. Acquisition route

   Our clinic obtains this device, made by "Innoxus Inc." (South Korea), via a domestic distributor, and uses it under the responsibility of the attending physician.

3. 3. Domestically approved equivalent devices

   There is no domestically approved medical device identical to this device using DLTD® (dielectric heating) technology.

   Domestically approved medical devices intended for similar effects include: Radiofrequency (RF) devices, High-Intensity Focused Ultrasound (HIFU) devices.

4. 4. Safety information from other countries

   This device has obtained approval from Korea Ministry of Food and Drug Safety (MFDS).

   This device has not been approved in the United States, Europe, or other major Western countries. Safety information is therefore limited, and significant risks may not yet have been identified.

※ The device used in this treatment is not approved in Japan. In the event of any health damage, it is not covered by Japan's Adverse Drug Reaction Relief System or any other national relief program.

This treatment may use medicines or injectable products that have not been approved under Japan’s Pharmaceuticals and Medical Devices Act. The following information is provided in accordance with the MHLW Medical Advertising Guidelines.

1. 1. Unapproved medicine

   The products used in this treatment may include "Botulax, Coretox", medicines or injectable products not approved in Japan.

2. 2. Acquisition route

   Our clinic obtains these products as products of "Hugel, Inc. (Botulax), Medytox, Inc. (Coretox)" (South Korea) via personal importation, and uses them under the responsibility of the attending physician.

3. 3. Domestically approved alternatives

   There may be no domestically approved product with the same ingredient and purpose.

   Domestically approved products used for similar purposes include: BOTOX VISTA (botulinum toxin type A product, Allergan Japan K.K., approved on January 21, 2009; available at our clinic).

4. 4. Safety information from other countries

   Approval status in other countries: Korea Ministry of Food and Drug Safety (MFDS)

   Botulax and Coretox have not received approval in Japan under the Pharmaceuticals and Medical Devices Act. For the treatment of frown lines between the eyebrows and crow's feet, you can choose Allergan's BOTOX VISTA, a medicine approved in Japan, at our clinic. Botulax has been approved by the Korea MFDS. In the United States, a product with the same active ingredient from the same company received FDA approval in 2024 under a different brand name (Letybo). This is not an approval of the product Botulax itself. Coretox is approved only by the Korea MFDS and has no approval in the United States or Europe. For personally imported medicines, there is no official guarantee that their manufacturing, quality, and safety are equivalent to those of medicines approved in Japan. For this intended use, safety information is limited, and significant risks may not yet have been identified. If health damage occurs, it is also not covered by Japan's Adverse Drug Reaction Relief System.

   For pharmaceutical products that have not been approved in major Western countries, safety information is limited, and significant risks may not yet have been identified.

※ Unapproved pharmaceutical products used in this treatment are not covered by Japan's Adverse Drug Reaction Relief System in the event of any health damage.

This treatment may use medical devices that have not received approval under Japan’s Pharmaceuticals and Medical Devices Act. The following information is provided in accordance with the MHLW Medical Advertising Guidelines.

1. 1. Unapproved medical device

   The products used in this treatment may include "Neuramis Light, Neuramis Deep, Neuramis Volume", medical devices that have not received approval under Japan’s Pharmaceuticals and Medical Devices Act.

2. 2. Acquisition route

   Our clinic obtains this device, made by "Medytox, Inc." (South Korea), via personal importation, and uses it under the responsibility of the attending physician.

3. 3. Domestically approved equivalent devices

   There is no identical domestically approved medical device.

   Domestically approved medical devices intended for similar effects include: Juvéderm Vista Volbella XC (Allergan Japan K.K.; available at our clinic), Juvéderm Vista Volift XC (Allergan Japan K.K.; available at our clinic), Juvéderm Vista Voluma XC (Allergan Japan K.K.; available at our clinic).

4. 4. Safety information from other countries

   This device has obtained approval from Korea Ministry of Food and Drug Safety (MFDS).

   Neuramis has not received approval in Japan under the Pharmaceuticals and Medical Devices Act. As medical devices approved in Japan that can be used for the same purpose, you can choose Juvéderm Vista Volbella XC, Volift XC, or Voluma XC at our clinic. Neuramis has been approved by the Korea MFDS. It has not received FDA approval in the United States. For personally imported medicines and medical devices, there is no official guarantee that their manufacturing, quality, and safety are equivalent to those of products approved in Japan. For this intended use, safety information is limited, and significant risks may not yet have been identified. If health damage occurs, it is also not covered by Japan's Adverse Drug Reaction Relief System.

※ Unapproved medical devices used in this treatment are not covered by Japan's Adverse Drug Reaction Relief System or any other national relief program in the event of any health damage.

This treatment may use medicines or injectable products that have not been approved under Japan’s Pharmaceuticals and Medical Devices Act. The following information is provided in accordance with the MHLW Medical Advertising Guidelines.

1. 1. Unapproved medicine

   The products used in this treatment may include "Juvelook, Rejuran, Jalupro, Pluryal, Sunekos, Pink Glow, Rittuo", medicines or injectable products not approved in Japan.

2. 2. Acquisition route

   Our clinic obtains these products as products of "VAIM (Juvelook, South Korea), PharmaResearch Co., Ltd. (Rejuran, South Korea), Professional Derma SA (Jalupro, Switzerland), MD Skin Solutions (Pluryal, Luxembourg), Professional Dietetics S.p.A. (Sunekos, Italy), and others" via personal importation, and uses them under the responsibility of the attending physician.

3. 3. Domestically approved alternatives

   There may be no domestically approved product with the same ingredient and purpose.

   Domestically approved products used for similar purposes include: SkinVive (Juvéderm Vista Volite XC; available at our clinic).

4. 4. Safety information from other countries

   The physician will explain the approval status in other countries during your consultation. For personally imported medicines and medical devices, there is no official guarantee that their manufacturing, quality, and safety are equivalent to those of products approved in Japan. Unexpected side effects or harm to health may occur, and even if such harm occurs, it is not covered by Japan's Adverse Drug Reaction Relief System. SkinVive (Juvéderm Vista Volite XC) is a product approved in Japan.

   For pharmaceutical products that have not been approved in major Western countries, safety information is limited, and significant risks may not yet have been identified.

※ Unapproved pharmaceutical products used in this treatment are not covered by Japan's Adverse Drug Reaction Relief System in the event of any health damage.

This treatment may use medicines or injectable products that have not been approved under Japan’s Pharmaceuticals and Medical Devices Act. The following information is provided in accordance with the MHLW Medical Advertising Guidelines.

1. 1. Unapproved medicine

   The products used in this treatment may include "Products used in skin-hydrating injections (Juvelook, Rejuran Healer, Pluryal Densify, Sunekos Performa, the Korean-made botulinum toxin product Skin Botox, etc.)", medicines or injectable products not approved in Japan.

2. 2. Acquisition route

   Our clinic obtains these products as products of "VAIM (Juvelook, South Korea), PharmaResearch Co., Ltd. (Rejuran Healer, South Korea), MD Skin Solutions (Pluryal Densify, Luxembourg), Professional Dietetics S.p.A. (Sunekos Performa, Italy), and others" via personal importation, and uses them under the responsibility of the attending physician.

3. 3. Domestically approved alternatives

   There may be no domestically approved product with the same ingredient and purpose.

   Domestically approved products used for similar purposes include: SkinVive (Juvéderm Vista Volite XC; available at our clinic).

4. 4. Safety information from other countries

   The physician will explain the approval status in other countries during your consultation. For personally imported medicines and medical devices, there is no official guarantee that their manufacturing, quality, and safety are equivalent to those of products approved in Japan. Unexpected side effects or harm to health may occur, and even if such harm occurs, it is not covered by Japan's Adverse Drug Reaction Relief System. SkinVive (Juvéderm Vista Volite XC) is a product approved in Japan.

   For pharmaceutical products that have not been approved in major Western countries, safety information is limited, and significant risks may not yet have been identified.

※ Unapproved pharmaceutical products used in this treatment are not covered by Japan's Adverse Drug Reaction Relief System in the event of any health damage.

This treatment may use medicines or injectable products that have not been approved under Japan’s Pharmaceuticals and Medical Devices Act. The following information is provided in accordance with the MHLW Medical Advertising Guidelines.

1. 1. Unapproved medicine

   The products used in this treatment may include "Jalupro GlowPeel", medicines or injectable products not approved in Japan.

2. 2. Acquisition route

   Our clinic obtains these products as products of "Professional Derma SA" via a wholesaler in Japan, and uses them under the responsibility of the attending physician.

3. 3. Domestically approved alternatives

   There may be no domestically approved product with the same ingredient and purpose.

4. 4. Safety information from other countries

   The physician will explain the approval status in other countries during your consultation. Jalupro GlowPeel has not received approval in Japan under the Pharmaceuticals and Medical Devices Act. For medicines and medical devices not approved in Japan, there is no official guarantee that their manufacturing, quality, and safety are equivalent to those of products approved in Japan. For this intended use, safety information is limited, and significant risks may not yet have been identified. If health damage occurs, it is also not covered by Japan's Adverse Drug Reaction Relief System.

※ Unapproved pharmaceutical products used in this treatment are not covered by Japan's Adverse Drug Reaction Relief System in the event of any health damage.

This treatment may use medicines or injectable products that have not been approved under Japan’s Pharmaceuticals and Medical Devices Act. The following information is provided in accordance with the MHLW Medical Advertising Guidelines.

1. 1. Unapproved medicine

   The products used in this treatment may include "LHALA Doctor", medicines or injectable products not approved in Japan.

2. 2. Acquisition route

   Our clinic obtains these products as products of "H2medi Co., Ltd." (South Korea) via a wholesaler in Japan, and uses them under the responsibility of the attending physician.

3. 3. Domestically approved alternatives

   There may be no domestically approved product with the same ingredient and purpose.

4. 4. Safety information from other countries

   The physician will explain the approval status in other countries during your consultation. LHALA Doctor has not received approval in Japan under the Pharmaceuticals and Medical Devices Act. For medicines not approved in Japan, there is no official guarantee that their manufacturing, quality, and safety are equivalent to those of medicines approved in Japan. For this intended use, safety information is limited, and significant risks may not yet have been identified. If health damage occurs, it is also not covered by Japan's Adverse Drug Reaction Relief System.

※ Unapproved pharmaceutical products used in this treatment are not covered by Japan's Adverse Drug Reaction Relief System in the event of any health damage.

The thread used in Thread Lift is a medical device not approved in Japan. Our clinic obtains it through a wholesaler in Japan. The physician will explain the manufacturer, whether a domestically approved product is available, and its approval status in other countries during your consultation. In the event of any health damage, it is not covered by Japan's Adverse Drug Reaction Relief System or any other national relief program.

The thread used in Shopping Lift is a medical device not approved in Japan. Our clinic obtains it through a wholesaler in Japan. The physician will explain the manufacturer, whether a domestically approved product is available, and its approval status in other countries during your consultation. In the event of any health damage, it is not covered by Japan's Adverse Drug Reaction Relief System or any other national relief program.