Korea Lifting Device Facts

Models, applicators and source documents · Research snapshot

Device record library

Published

Find model-specific records without merging names, accessories or regulatory scopes.

The model records cover Oligio generations, surface RF, named accessory families and ultrasound systems. Each keeps its own evidence limits.

  • StatisticsKorea Oligio models

    Oligio models: A name on a quotation can identify a product family without identifying the exact console or tip.

  • StatisticsKorea surface RF devices

    Surface RF records: Thermage FLX, Volnewmer, 10THERMA, DENSITY and XERF share an RF label but retain different device and indication records.

  • StatisticsKorea DENSITY names

    DENSITY names: Names on a manufacturer advertisement and names in a US submission answer different questions.

  • StatisticsKorea POTENZA tips

    POTENZA applicators: The brand name alone does not answer whether needles are used.

  • StatisticsKorea InMode handpieces

    InMode handpieces: InMode is a manufacturer name, while a quotation may refer to a console, a handpiece or a treatment label. The exact accessory determines which source description applies.

  • StatisticsKorea Ulthera versions

    Ulthera versions: A new US event can add a body-area scope while an older online IFU remains unchanged.

  • StatisticsKorea Shurink model names

    Shurink model names: A naming relationship can help locate an English document without proving that every jurisdiction uses identical hardware and cartridges.

  • StatisticsKorea Sofwave modules

    Sofwave modules: The selected SofWave System documents contain more than one module.

Which device record should be opened first?

Choose the generation or accessory question that matches the name you already have.

Oligio and DENSITY records resolve name relationships, while POTENZA and InMode records distinguish accessories. Ultrasound records separate legacy systems, PRIME revisions, regional names and modules.

Where do these numbers come from?

  1. K243929 : Oligio X · US FDA 510(k) clearance (United States) · U.S. Food and Drug Administration · Primary source Research access: 2026-10-24. Decision letter identity/date; indications-for-use enclosure and/or summary; device-description/technology sections. Selected sections only, not a full IFU or full dossier.
  2. K231287 : POTENZA · US FDA 510(k) clearance (United States) · U.S. Food and Drug Administration · Primary source Research access: 2026-10-24. Decision letter identity/date; indications-for-use enclosure and/or summary; device-description/technology sections. Selected sections only, not a full IFU or full dossier.
  3. 의료기기안심책방 · Korea MFDS portal entry page · Ministry of Food and Drug Safety · Primary source Research access: 2026-10-24. Landing-page text only. Product-level search/permit attachments were not retrieved. No permit number or current Korea indication inferred.