韓国で調べるサーマクールFLXとは？RFと冷却の仕組み・注意点

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. Thermage — System Indications and Important Safety Information ↗確認日 2026-11-03 · 出典1
   確認に使った記述

   Do not undergo Thermage ® treatment if you have a cardiac pacemaker, a cardioverter, a defibrillator, or any other electrical implant. [...] Solta Medical has not studied the use of the Thermage ® system: Over skin fillers (lips, cheeks, facial wrinkles and skin folds) In people who are pregnant and/or breast feeding, diabetic, have an auto-immune disease such as lupus, have cold sores, have genital herpes, or have epilepsy In people who have permanent make-up and/or tattoos In children [...] The most commonly reported adverse effect during treatment is mild to moderate pain in the area being treated. [...] Mild redness may occur and typically resolves within 24 hours. Swelling may occur and typically resolves within 5 days, but can remain up to several weeks. The following adverse effects occur infrequently: The procedure may produce heating in the upper layers of the skin, causing burns and subsequent blister and scab formation. There is a possibility of scar formation. Skin surface irregularities may appear up to 1 or more months post-treatment. Numbness, tingling” or temporary paralysis may occur; typically resolves in a short period of time but may persist up to several weeks. Lumps or nodules may occur under the skin primarily in the neck area, and usually resolve within 1 or 2 weeks without chronic or long-term complications. Skin may darken, but normally resolves within several months. [...] All information and materials on this site pertain to the U.S. only, unless otherwise indicated.

2. FDA K170758 — Thermage FLX System：決定書・使用目的・510(k)要約 ↗確認日 2026-11-03 · 出典2
   確認に使った記述

   [Page 4] Device Name Thermage FLX System [...] Thermage ThermaCool CPT cleared under K090580 on June 26, 2009 [...] The Thermage FLX System delivers RF energy for selective coagulation of tissue while conductively cooling the epidermis. [...] The System and its Handpiece monitor skin contact during treatment. The System employs RF tuning to provide RF energy across a range of impedances [...] [Page 5] The radiofrequency (RF) energy delivery components [...] Non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids; [...] The simultaneous application of radiofrequency energy and skin vibration [...] Temporary improvement in the appearance of cellulite; [...] [Page 7] Brief Summary of Nonclinical Tests and Results [...] [Page 8] Non-clinical test results demonstrate that the Thermage FLX System is substantially equivalent to the predicate devices and no new issues of safety or effectiveness have been raised.

3. FDA 510(k) Premarket Notification — K170758 ↗確認日 2026-11-03 · 出典3
   確認に使った記述

   510(k) Number K170758 Device Name Thermage FLX System and Accessories [...] Decision Date 09/22/2017 Decision Substantially Equivalent (SESE)

4. 厚生労働省 — 医療機器の電子化された添付文書の記載要領について ↗確認日 2026-11-03 · 出典4
   確認に使った記述

   2．記載項目及び記載順序 (1) 作成又は改訂年月 (2) 承認番号等 (3) 類別及び一般的名称等 (4) 販売名 (5) 警告 (6) 禁忌・禁止 (7) 形状・構造及び原理等 (8) 使用目的又は効果 (9) 使用方法等 (10) 使用上の注意 [...] 承認番号、認証番号又は届出番号のいずれかを記載する [...] 承認又は認証を受けた使用目的又は効果を記載すること。

5. 厚生労働省 — サーマクール（Thermage）トリートメント・チップの使用に関する注意喚起 ↗確認日 2026-11-03 · 出典5
   確認に使った記述

   [Page 1] サーマクール（Thermage）トリートメント･チップの使用に関する注意喚起について [...] 平成 29 年 2 月 16 日

6. 韓国MFDS 医療機器公開検索 — 수허18-245호 ↗確認日 2026-11-03 · 出典6
   確認に使った記述

   "수허18-245호" 에 대한 의료기기 검색 결과입니다. 총 1 건 [...] 1 솔타메디칼코리아 유한회사 범용 전기 수술기 수허18-245호 3 정상 A35010.01 Thermage FLX System, 써마지FLX, 써마지 TG-3A 2018-08-21 2018004887 2020-10-08~2029-11-30

7. 東京美容皮膚科クリニック — サーマクールFLX・薬機法上の承認について ↗確認日 2026-11-03 · 出典7
   確認に使った記述

   サーマクールFLXについて [...] 薬機法上の承認について この治療法で用いられる医薬品・医療機器は国内においては薬機法上の承認を受けていません。

AIを調査・下書き・出典の照合に利用し、運営者の公開承認に基づいて掲載しています。AIによる検証は専門家の監修を意味しません。