# Can an older device IFU show every current use?

> An older instruction file records its own revision and scope, while later regulatory events remain separate records to match.

Ulthera PRIME has later body-area events not all present in the older instruction file reviewed. Their dates and configuration relationships remain visible rather than silently updating the old text.

Written by the Monun Device Research Group editorial team on October 25, 2026. Canonical address: https://kliftingdevices.site/articles/historical-ifu.

## What does an IFU revision identify?

It identifies the instruction file actually reviewed, not every current document associated with a brand.

The older PRIME file names its revision. The research read selected indications and system-identity sections rather than the entire manual. Those facts remain part of the source record so a later claim can be traced to what was actually read.

**An IFU record needs version and reading scope**

| Field | Why it matters | Unresolved issue |
| --- | --- | --- |
| Revision | Identify the actual file | Current local revision may differ |
| Sections read | Bound the statement | Not a full manual audit |
| Model | Match the console | Do not apply to every old unit |
| Jurisdiction | Keep local use scope | US text does not establish Korean permit |

## Which later PRIME events were verified?

Separate records preserve PRIME identity, body-area and model-revision events.

The sequence includes an initial PRIME record, an expanded body-area record, PRIME Model2.1 and a knee-skin-laxity appearance event. The table provides identifiers and source dates. This selected history does not claim that no other event exists.

**Selected Ulthera events and source dates**

| Event | Date | Scope kept separate |
| --- | --- | --- |
| K233996 | 2024-02-22 | UC-1 PRIME identity |
| K243035 | 2025-02-24 | Abdomen and anterior/posterior arms |
| K250418 | 2025-05-13 | PRIME Model2.1 |
| K260618 | 2026-05-21 | Appearance of knee skin laxity |

## Does omission from an old IFU prove a later use never existed?

A later event can fall outside the older file; omission alone does not establish nonexistence.

The relationship is temporal and document-specific. The old instruction keeps its wording, while a later event has a different identifier and date. A complete current match needs the relevant model label and current local instructions.

## Does the newest event update every older console?

The event must be matched to its model and configuration, not applied to every earlier unit.

The knee event describes the Ulthera System and its predicate relationship, with no hardware, software or firmware change stated in that submission. This bounded statement does not establish Korean labeling or applicability to every legacy control unit.

## How should historical imaging descriptions be retained?

DeepSEE identity stays with the instruction revision and sections read.

Imaging and body-area indications are different fields. One can be documented in an older instruction and another in a later event. The catalog does not turn this into one undated current-feature card or a clinical-performance ranking.

## Can a later US event confirm Korean instructions?

The US event does not supply the current Korean label, permit or instruction revision.

A Korean trade name may need a local configuration match. A domestic permit carries its own permit date, and the US date is not a Korean release date. These limits remain beside the overseas history without invalidating that limited record.

## What belongs in a version change log?

Keep both sources, their model relationship and the wording supported by each.

A current instruction or permit can update the record. Earlier observations remain dated, while a superseding relation explains what changed. A document comparison does not select a treatment area, depth or eligibility for a reader.

## What else do people ask about Historical IFU scope?

### Was the full older PRIME manual read?

Only selected indications and identity sections were read.

### Does omission mean a later use never existed?

An older file may precede a later event; compare both dated records.

### Is the latest decision a Korean launch date?

It dates a US event rather than Korean distribution.

### Does a new event cover every legacy unit?

Exact model and configuration matching is necessary.

### Can the log choose treatment settings?

It explains documents without selecting personal settings.

## What should you read next?

- [What does FDA clearance mean for a lifting device?](https://kliftingdevices.site/articles/clearance-and-approval)
- [Why do RF frequency records differ across sources?](https://kliftingdevices.site/articles/frequency-conflicts)
- [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 : 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