# Korea Ulthera versions

> Ulthera legacy instructions, PRIME control units and later body-area events retain separate model and document revisions.

A new US event can add a body-area scope while an older online IFU remains unchanged. The record date and the exact control-unit label determine which document relationship has been established.

Written by the Monun Device Research Group editorial team on October 25, 2026. Canonical address: https://kliftingdevices.site/statistics/ulthera-version-events.

## Which Ulthera versions are distinguished?

Legacy instructions and PRIME records are separate entries, with later PRIME model revisions retained.

The legacy entry is identified through a selected section of a US instruction manual. PRIME has its own control-unit submission, followed by version and body-area records. A reader who only knows the Ultherapy service name cannot assume that every console uses the latest configuration described by those documents.

**Ulthera identity and event records; research 2026-10-24**

| Exact record | Energy family | Verified US document and event date | Korean MFDS permit |
| --- | --- | --- | --- |
| Ulthera System / Ultherapy (legacy IFU) | Ultrasound | No matched US event in this research | MFDS 수허09-1024호 (2009-10-13) |
| Ulthera System PRIME | Ultrasound | K233996 (2024-02-22); K243035 (2025-02-24); K250418 (2025-05-13); K260618 (2026-05-21) | MFDS 수허09-1024호 (2009-10-13) |

## What changes across the selected Ulthera events?

The records distinguish the PRIME control unit, later model version and expanded body-area wording.

The original PRIME record, the abdominal and arm-area event, the Model 2.1 record and the knee-area event are not substituted for one another. Their identifiers make it possible to return to the correct enclosure. A technical comparison can explain what changed relative to a predicate while the subject document still controls its own indications.

**Selected Ulthera event relationships**

| Document | Relationship to preserve | Not transferred |
| --- | --- | --- |
| K233996 | PRIME control-unit record | Every older console |
| K243035 | Abdomen and anterior / posterior arm appearance scope | Korean permit |
| K250418 | PRIME Model 2.1 configuration | All previous instructions |
| K260618 | Knee skin-laxity appearance scope | All local models and indications |

## Which Ulthera record includes knee skin laxity?

The selected US event K260618 includes knee skin-laxity appearance alongside its retained indications.

The claim checker displays this event from the dated snapshot. Its applicability remains attached to the Ulthera System and the documented relationship to the PRIME predicate. The event does not establish an individual treatment result, a Korean indication or an update to every older manual available online.

## What does Ulthera imaging identify?

The reviewed IFU sections describe DeepSEE visualization as a distinct system function alongside treatment delivery.

Visualization, treatment depth and a transducer label are different fields. An imaging function documented for Ulthera cannot be assigned to another ultrasound device merely because it also uses focused energy. The source relationship establishes what the system description contains; it does not validate a consumer choosing a depth or interpreting a tissue image.

## Can an older Ulthera IFU establish the newest scope?

An older revision documents its own text and cannot establish that a later indication is absent or already included.

The accessed PRIME IFU retained the earlier eyebrow, submental, neck and décolleté wording. Later US documents are therefore read as separate events rather than silently inserted into the old file. A missing later body area in an old manual can reflect document age; it is not enough to decide the current authorization status of a precisely identified device.

## Do Ulthera US events verify a Korean permit?

Korean model labels, current permits and amendments have not been matched in this source collection.

A US identifier belongs to the US field. Copying it into a domestic permit field would erase the jurisdiction distinction. Korean names, cartridge identifiers and label revisions need their own relationship to the current domestic document. Unmatched evidence does not establish unauthorized use or lack of local availability.

## How should an Ulthera record be checked against a quotation?

Keep the control unit, transducer, intended body area and document revision identifiable before linking a claim.

A quotation may omit whether its name refers to a legacy system or PRIME. That is an identity gap rather than proof of a particular generation. The selected-source table supports the document comparison, while treatment settings, shot equivalence and personal outcome predictions remain outside the catalog.

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 else do people ask about Ulthera versions?

### Does the PRIME name identify Model 2.1?

The control-unit label and the matching document must distinguish the particular revision.

### Does an event date establish a Korean launch?

It dates the selected US regulatory event; domestic launch needs its own source.

### Can the knee event be applied to all old consoles?

The exact system and predicate relationship remain attached to the event.

### Is a missing body area in an old IFU a current prohibition?

An old revision alone does not determine the current scope; later documents require separate comparison.

### Does the model record choose a transducer depth?

The record identifies sources and accessories without selecting treatment parameters.

## What should you read next?

- [What does FDA clearance mean for a lifting device?](https://kliftingdevices.site/articles/clearance-and-approval)
- [Why identify the console, handpiece and tip?](https://kliftingdevices.site/articles/console-and-tip)
- [Korea lifting model lookup](https://kliftingdevices.site/tools/model-finder)
- [Korea device indication checks](https://kliftingdevices.site/tools/claim-checker)

## Where do these numbers come from?

- [Ulthera System Instructions for Use : 1015107IFU Rev 05](https://ultherapy.com/app/themes/ultherapy2020/pdfs/1015107IFU-Rev-05-US-Ultherapy.pdf) - Ulthera : US instructions for use
- [Ulthera System Instructions for Use : 1016413IFU Rev 00](https://ultherapy.com/app/themes/ultherapy2020/pdfs/ultherapy-prime-instructions-for-use.pdf) - Ulthera : US instructions for use
- [K233996 : Ulthera System (UC-1 Control Unit PRIME)](https://www.accessdata.fda.gov/cdrh_docs/pdf23/K233996.pdf) - U.S. Food and Drug Administration
- [K243035 : Ulthera System](https://www.accessdata.fda.gov/cdrh_docs/pdf24/K243035.pdf) - U.S. Food and Drug Administration
- [K250418 : Ulthera System (UC-1 Control Unit PRIME Model 2.1)](https://www.accessdata.fda.gov/cdrh_docs/pdf25/K250418.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
- [Medical device item search (의료기기안심책방): lifting device permits](https://emedi.mfds.go.kr/search/data/MNU20237) - Ministry of Food and Drug Safety