Devices with an MFDS medical-device licence number on record

Devices with an MFDS medical-device licence number on record (checked 2026-09-17). Matched on company name + model name (or manufacturer of record). A device missing from this list is neither confirmed to require a licence nor confirmed unlicensed — this is not a determination of whether a licence is required.

• [아크제로 (ACZERO) \[ \] 의료기기](https://device.btyspecs.com/en/products/homethera/%EC%95%84%ED%81%AC%EC%A0%9C%EB%A1%9C-aczero-%EC%9D%98%EB%A3%8C%EA%B8%B0%EA%B8%B0) — HOMETHERA · MFDS medical-device licence no. 제허 18-564 호 (MFDS risk class 3 · ACZERO-Gold Edition외 1건 · checked 2026-09-16 · basis: 허가번호 직접조회(제허 18-564 호) · 확인일 2026-09-16 · 식약처 품목허가 Open API(15057456) · 품목명 개인용광선조사기 · 등급 3 · 업체 (주)하이로닉)

This page lists licence, certification and cost information only — not efficacy information. An MFDS medical-device licence lookup result (with its check date) is not a determination of whether a licence is required. Not affiliated with the MFDS or the National Radio Research Agency.