Korea Lifting Device Facts

Models, applicators and source documents · Research snapshot

Lifting device glossary

Published

Read energy, accessory and authorization terms within the source role that defines them.

A circuit term, a body-area indication and a label identifier describe different fields even when they appear in one product description.

Console
The platform to which documented handpieces and accessories connect. The console name does not identify every tip.
Handpiece
An applicator attached to a system; its delivery method and indications may differ from another handpiece on the same platform.
Tip or cartridge
A specific treatment accessory whose identity remains part of the model and document match.
Radiofrequency (RF)
RF systems in these records deliver electrical energy through specified electrodes and accessories.
Monopolar RF
An RF circuit uses an active treatment electrode and a separate patient return electrode to complete the electrical loop. Circuit type does not rank outcomes or determine skin penetration.
Bipolar RF
RF energy travels between two electrodes without a separate neutral return pad. The circuit may use penetrating or noninvasive applicators, so the actual tip determines skin penetration.
RF microneedling
RF delivery through penetrating needle electrodes; a platform with noninvasive tips needs accessory-level distinction.
Microfocused ultrasound
The focused-ultrasound architecture named in the Ulthera system documents, with its own system and accessory scope.
Ultrasound visualization
A documented imaging function such as DeepSEE; ultrasound branding alone does not verify the same function on another device.
Parallel-beam ultrasound
The SUPERB ultrasound architecture described for Sofwave, kept separate from focused ultrasound and electrical muscle modules.
Indications for use
The device-specific intended use described in the relevant document, including accessory and body-area conditions.
510(k) clearance
The US substantial-equivalence decision for the subject device and stated indications; distinct from PMA approval and Korean authorization.
Predicate device
A device legally marketed in the United States and used in a substantial-equivalence comparison; its indications do not automatically transfer to the subject device.
Instruction for use (IFU)
A revision-specific instruction document. Later regulatory events may fall outside an older version.
Unique Device Identifier (UDI)
UDI is a unique identifier on a device label. It can be used with the GUDID device record to match the labeler and model; it does not replace the indications document.
Lot
A label identifier needed when a recall is limited to specified batches rather than every product with the brand name.
Unverified Korean permit
No MFDS item record matched the product or model name in this research; it is not a finding of unauthorized use.
Source reading extent
The sections actually checked, distinguished from an abstract, indexed excerpt, file download or complete manual.

How should lifting device glossary terms be combined?

Use one field for each term: energy, delivery, identity, jurisdiction or document revision.

Monopolar RF describes a circuit, while a penetrating tip describes delivery and clearance identifies a regulatory pathway. None of those words alone selects a treatment for a person. Source links retain the document behind the definition.

What else do people ask about lifting device glossary?

Are glossary definitions device recommendations?

They explain source terms without selecting a treatment.

Does RF always mean a needle?

The exact electrode and applicator determine penetration.

Does IFU mean the newest record?

The revision needs checking against later events.

Does an identifier state an indication?

Identification and indications have separate document roles.

Does unverified mean absent?

It records a gap in this research rather than the absence of authorization.

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. Ulthera System Instructions for Use : 1015107IFU Rev 05 · Manufacturer material (not a permit) · Ulthera : US instructions for use · Primary source Manufacturer first-party identity/technical source, not independent clinical evidence. Research access: 2026-10-24. Sections 2.1 indications and DeepSEE imaging, system identity. Only these selected sections; not the entire 72-page manual.
  4. AccessGUDID - DEVICE: Oligio X (08800022305327) · US FDA/NIH device identifier, UDI (United States) · U.S. National Library of Medicine : AccessGUDID · Primary source Research access: 2026-10-24. Oligio X model/labeler and links to K240313/K243929. GMDN generic contouring definition is not used as device-specific clearance evidence.