# Korea device indication checks

> Compare a curated question with its exact jurisdiction, model and source rather than treating approval language as a universal claim.

Choose a document question and a jurisdiction. Missing Korean permits, selected US indications and a specified-tip recall remain separate results.

Written by the Monun Device Research Group editorial team on October 25, 2026. Canonical address: https://kliftingdevices.site/tools/claim-checker.

## Which questions can device indication checks compare?

The tool uses predefined questions about Oligio X, a US Ulthera knee record and a specified XERF tip recall.

Each question has a model and source identifier before the reader selects an answer condition. The tool does not infer a diagnosis from a sentence or accept an arbitrary marketing claim as verified evidence. A result names the matched record and preserves missing conditions. This keeps the comparison reproducible from the same deployed documents.

## Which conditions must device indication checks keep together?

Jurisdiction, model revision, accessory, body area and event identifier describe the document scope together.

A device name can recur across several revisions. A use added to a later US document does not automatically update an older manual or a Korean label. Accessory-specific wording also stays attached to its accessory. The comparison displays the source relationship without ranking devices by expected benefit or comfort.

**Fields that control a document comparison**

| Field | Why it matters | Example |
| --- | --- | --- |
| Jurisdiction | A US decision is a US record | US versus Korean permit |
| Revision and accessory | New scope may be configuration-specific | PRIME version; EFFECTOR 60 |
| Event date | Dates a regulatory event | Not a Korean launch date |

## Can device indication checks confirm Korean Oligio X authorization?

K243929 is a US record for noninvasive soft-tissue electrocoagulation and hemostasis; the Korean permit is a separate MFDS record, 제허23-860호.

Selecting Korea does not copy the FDA identifier into a domestic permit field. A current MFDS product permit, exact local model and accessory label would be needed for that relationship. The US record remains available for reading its own indications. Its pathway is described as 510(k) clearance rather than a blanket lifting approval.

## Which Ulthera event appears in device indication checks?

The knee question matches US event K260618 dated 2026-05-21, preserving its model and body-area scope.

The source describes the appearance of knee skin laxity within the Ulthera System indications. The decision date is not a product launch date or a statement about every legacy console. Other PRIME records have their own dates and configurations. The comparison therefore uses the selected event rather than a single undated approval label.

## How do device indication checks read the XERF recall?

The recall comparison requires the named EFFECTOR 60 tip and listed catalog numbers and lots rather than the XERF brand alone.

The selected recall record is Z-0146-2026. A missing lot produces a request to match the label. A listed lot is shown as appearing in that dated record, while an unlisted entry remains outside that record. Neither an omitted lot nor a non-match becomes a safety conclusion.

The source also records the displayed status and the official action. Consumers can read those conditions in the original document without treating a selected-tip recall as a recall of every console and accessory.

**Recall inputs and bounded outputs**

| Input condition | Displayed relationship | Boundary |
| --- | --- | --- |
| Tip or lot missing | Label matching is incomplete | No all-platform conclusion |
| Listed tip and lot | Entry occurs in the selected record | Match catalog number and official action |
| Lot not listed | Absent from this selected record | No certification of safety |

## What is the reference basis for device indication checks?

The comparison uses 2026-10-24 research records with source identifiers, event dates and reading limits.

The event collection contains 18 unique selected US 510(k) documents. A document may connect to more than one accessory, so event-to-model relationships are not counted as independent clearance documents. The selected collection is not a complete authorization or recall history.

Some source reviews cover only decision identity, indications and technical sections. Full manuals, domestic amendments and newly issued records require separate checking.

## What does device indication checks avoid collecting or deciding?

The tool uses local document choices and label text without collecting health records or determining personal treatment suitability.

The inputs contain a question, a jurisdiction and optional tip or lot text. They are not placed in the URL, retained as a patient profile or uploaded for diagnosis. Opening a source is an ordinary navigation to the publisher. A result supports document reading and consultation questions; it does not prescribe settings, predict outcomes or guarantee legal compliance.

A device name, US clearance or manufacturer description does not establish personal suitability or Korean authorization. These records are a dated source collection, not a complete clearance, recall or market inventory.

## What basis are these numbers on?

| Data | Reference date | Site calculation |
| --- | --- | --- |
| Selected US regulatory events | October 24, 2026 | - |
| Curated document questions | October 24, 2026 | - |
| Source provenance | October 24, 2026 | - |

## What else do people ask about device indication checks?

### Can I paste any advertisement for a verdict?

No. The tool compares predefined document questions and does not interpret arbitrary medical claims.

### Why show US records after I select Korea?

The result separates the US evidence from the Korean MFDS permit record rather than treating them as interchangeable.

### Does a recall lot match identify my whole device?

A lot match still needs the named tip, catalog number and actual label to align.

### Can the tool predict a safe setting?

It does not calculate treatment energy, depth or shots.

### Does an absent event mean no safety concern?

Absence means it was not captured in this selected collection; it does not establish safety.

## What should you read next?

- [Do predicate devices share every indication?](https://kliftingdevices.site/articles/predicate-limits)
- [Which models and lots does a device recall cover?](https://kliftingdevices.site/articles/recall-scope)
- [Korea Oligio models](https://kliftingdevices.site/statistics/oligio-generation-records)
- [Korea Ulthera versions](https://kliftingdevices.site/statistics/ulthera-version-events)

## Where do these numbers come from?

- [K243929 : Oligio X](https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243929.pdf) - U.S. Food and Drug Administration
- [K260618 : Ulthera System](https://www.accessdata.fda.gov/cdrh_docs/pdf26/K260618.pdf) - U.S. Food and Drug Administration
- [Class 2 Device Recall XERF EFFECTOR 60](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=216122) - U.S. Food and Drug Administration
- [의료기기안심책방](https://emedi.mfds.go.kr/) - Ministry of Food and Drug Safety
- [Medical device item search (의료기기안심책방): lifting device permits](https://emedi.mfds.go.kr/search/data/MNU20237) - Ministry of Food and Drug Safety