韓国で調べるウルセラとは？Ultherapy PRIMEの名前・仕組み・リスク

出典と確認日

記述の根拠をたどれるよう、参照先と確認日を掲載しています。

1. Ultherapy 米国メーカー公式サイト ↗確認日 2026-11-03 · 出典1
   確認に使った記述

   “micro-focused ultrasound energy and real-time imaging”; “Ultherapy and Ultherapy PRIME”

2. FDA K233996 — Ulthera System (UC-1 Control Unit PRIME), 2024 ↗確認日 2026-11-03 · 出典2
   確認に使った記述

   p.1: “Trade/Device Name: Ulthera System (UC-1 Control Unit PRIME)”; “substantially equivalent”; “do not require approval of a premarket approval application (PMA).” p.6: “Low-intensity, highly focused ultrasound”; “produces discrete points of thermal coagulation”; “ultrasonic visualization of depths up to 8 mm below the surface of the skin”; “Ensure proper coupling of the transducer to the skin”; “Confirm appropriate depth of treatment such as to avoid bone”; “Identical ultrasound signal energy and ultrasound treatment guidelines”. p.7: “Updates to the console’s industrial design and modernization of the graphics within the graphical user interface (GUI)”; “Hardware updates to comply with the latest electromedical standards and address end-of-life components”.

3. FDA K260618 — Ulthera System Expanded Indications (Knees), 2026 ↗確認日 2026-11-03 · 出典3
   確認に使った記述

   p.5: “Date Prepared: 12 May 2026”; “Ulthera ® System (UC-1 Control Unit PRIME), Ulthera, Inc., K250418”. p.6: “temporary changes in the physical appearance of the skin”; “Lift the eyebrow”; “Lift lax submental (beneath the chin) and neck tissue”; “Improve lines and wrinkles of the décolleté”; “Improve the appearance of skin laxity on the abdomen, anterior arms, posterior arms, and knees”; “There are no changes in design, hardware, or software between subject and predicate device.” p.8: “three (3) unique clinical studies”; “44 total subjects”; “up to 180 days”; “blinded clinician photographic assessment”; “physician and subject Global Aesthetic Improvement Scores (GAIS), and patient satisfaction surveys.” p.9: “real-world data (RWD) gathered from clinicians”; “global post marketing surveillance of the device”.

4. Ulthera System Instructions for Use — Ultherapy PRIME、米国版、2026 ↗確認日 2026-11-03 · 出典4
   確認に使った記述

   PDF p.8: “Open wounds or lesions in the treatment area”; “Severe or cystic acne in the treatment area”; “Active implants (e.g., pacemakers or defibrillators), or metallic implants in the treatment area”; “Mechanical implants”; “Dermal fillers”; “Breast implants”; “has not been evaluated for use in patients on an anticoagulant treatment plan”; “Pregnant or breast-feeding women”; “Children”; “Thyroid gland, thyroid cartilage and trachea”; “Major vessels and nerves”; “Breast tissue”; “Eyes, eyelids, and within the orbital rim”. PDF p.9: “A hemorrhagic disorder or hemostatic dysfunction”; “An active systemic or local skin disease that may alter wound healing”; “Herpes Simplex”; “Autoimmune Disease”; “Diabetes”; “Epilepsy”; “Bell’s Palsy”; “where ultrasound energy can reach the eye”; “typically resolves within a few hours”; “3 to 72 hours”; “This typically resolves within a week.”; “Tenderness to the touch is also possible and typically resolves within 2 days to 2 weeks of treatment.”; “2 to 6 weeks”; “burns, which may or may not result in permanent scar formation”. PDF p.10: “3 to 48 hours”; “1 day to 3 weeks”; “4 days to 5 weeks”; “resolve within a few hours to 2 weeks after treatment”; “reported voluntarily from a population of uncertain size”; “not always possible to reliably estimate their frequency or establish a causal relationship”. PDF p.11: “Fat/volume loss”; “Skin sagging/drooping, asymmetry”; “Palsy, paresis (muscle weakness)”; “Vision changes”; “nerve effects lasting for months have been described”.

5. 厚生労働省：医師免許を有しない者が行った高密度焦点式超音波を用いた施術について、2024年6月7日 ↗確認日 2026-11-03 · 出典5
   確認に使った記述

   「高密度焦点式超音波(High Intensity Focused Ultrasound。以下『HIFU』という。)」「急性白内障や神経麻痺等」「用いる機器が医療用であるか否かを問わず」「医師免許を有しない者が業として行えば医師法第17条に違反すること。」「医師による本行為は、医療法(昭和23年法律第205号)第1条の2第2項に規定する医療提供施設において行うこと。」

6. 韓国食品医薬品安全処 医療機器公開検索：수허09-1024호 ↗確認日 2026-11-03 · 出典6
   確認に使った記述

   “품목명 품목허가번호 품목등급 품목상태”; “제품명 모델명 품목허가일자”; “멀츠아시아퍼시픽피티이엘티디 집속형초음파자극시스템 수허09-1024호 3 정상 A35100.03 Ulthera system, Ulthera Prime, Ultherapy Prime Ultherapy Prime 2009-10-13 2009004877 2020-10-08~2031-09-30”

7. Merz Aesthetics Korea：ULTHERAPY PRIME ↗確認日 2026-11-03 · 出典7
   確認に使った記述

   “울쎄라피 프라임™”; “시각화된 마이크로포커스 초음파(MFU-V)”; “식품의약품안전처에서 허가를 받은 집속된 초음파로 조직을 응고하여 눈썹, 늘어진 턱선, 가슴윗부분을 리프팅하고 가슴윗부분(Decollete)의 주름(wrinkles)을 개선하는데 사용하는 의료기기(허가받은 품목명 : 집속형초음파자극시스템) 입니다.”

8. 湘南美容クリニック：ウルセラプライム導入についてのニュースリリース、2026年1月16日 ↗確認日 2026-11-03 · 出典8
   確認に使った記述

   「2026年1月16日」「日本初導入となる次世代HIFU治療器『ウルセラプライム』」「なお、日本国内においては薬事未承認の医療機器となります」

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