How is a Korean device permit matched to a model?
A Korean permit match requires the exact domestic model and current permit records; a US letter or product introduction cannot fill that gap.
A device can have a familiar trade name but an unmatched legal model or accessory. The MFDS portal and an older public product introduction have different roles, so their confirmation states remain separate.
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Where does Korean permit matching start?
It starts with the exact label and accessory identity rather than the short name on a treatment menu.
A commercial name can group several versions. Manufacturer naming evidence can connect Shurink Universe with ULTRAFORMER MPT, but the name relationship alone does not establish identical domestic hardware or permitted use. The local model and accessory remain separate fields.
| Field | Evidence to retain | Unresolved value |
|---|---|---|
| Trade name | Exact wording and source | Do not replace legal model |
| Model | Actual domestic label | Keep unknown visible |
| Accessory | Handpiece and tip identifiers | Do not infer from console |
| Revision | Instruction or model revision | Do not treat old text as current |
What does reaching the MFDS portal establish?
A portal landing page establishes an entry point, not a completed product-level permit match.
The research reached the portal but did not recover matched product permits and attachments for the initial device records. The absence is documented as a research gap. Neither a successful connection nor a search result title supplies the missing current permit text.
How does the older MFDS product introduction help?
The historical introduction names Ultraformer III and a purpose, but it is not the current permit detail.
An agency publication is an authoritative source for what that publication says. It does not automatically update with every subsequent model, tip or indication change. The introduction supports a bounded historical statement; the current domestic permit is read from the item record (제허14-1422호).
| Source | Useful for | Cannot replace |
|---|---|---|
| MFDS portal landing | Official query entry point | Matched product permit |
| MFDS item search record | Permit number, holder, dates, model name | Label of the installed unit |
| Historical agency introduction | What was named and described then | Current amendments |
| Manufacturer naming report | Documented trade-name relationship | Domestic legal identity |
| US clearance | Its US model and indication scope | Korean permit |
Why match Korean accessories separately?
Console identity does not identify every handpiece, cartridge or tip connected to it.
A platform may support different energy delivery branches. A local accessory label can therefore be necessary to interpret penetration, imaging and use restrictions. A shared brand or a translated nickname cannot resolve a missing accessory record.
Why retain permit amendments and revisions?
A dated record can describe one configuration while later documents address another scope.
A newer date alone does not establish that every console or local label changed. The match needs the document relationship and relevant configuration. Old source text is kept as historical rather than silently rewritten into the current local indication.
What does an unmatched Korean permit mean?
It means the research has not verified the current permit-to-label relationship.
When no MFDS item record matches the product or model name, the permit-number field stays unverified. A manufacturer footer or advertising review identifier is not copied into it. Uncertainty remains attached to the specific missing record, while verified model naming or foreign events can still be read within their own limits.
What information makes a Korean permit claim traceable?
A traceable claim retains model, accessory, jurisdiction, document revision, source link and actual reading scope.
These fields let a reader return to the document rather than trust an unqualified approval badge. The catalog lists an MFDS permit number only where the product or model name matched and keeps the rest unverified. Clinical suitability and treatment settings require different evidence and are not derived from this checklist.
What else do people ask about Korean permit matching?
Is a portal search a completed permit check?
Only a matched product record and its relevant text can establish the intended verification scope.
Can a trade name replace a legal model?
A naming relationship helps retrieval, but the legal model still requires a label match.
Is the historical MFDS introduction current authorization?
It supports the bounded historical description, not the current permit detail.
Can a US identifier fill the Korean permit field?
No. Jurisdictions and document types remain separate.
Does an empty permit field mean illegal use?
It records incomplete verification, without a legal finding about a particular use.
Where do these numbers come from?
- Medical device item search (의료기기안심책방): lifting device permits Checked 2026-10-25 by product or model name. Permit number, holder, item, product and model name, permit date, validity and export-only flag were read from the item records. Attached technical documents were not read; model lists shown as 'and N more' were not expanded.
- 의료기기안심책방 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.
- Products | Medical Devices | Our Works | Ministry of Food and Drug Safety : CLASSYS Research access: 2026-10-24. Product section names Ultraformer III and intended use eyebrow lifting; registration/publication date 2016-03-31. Attachments and current permit status not read.
- CLASSYS ESG Report 2022 Manufacturer first-party identity/technical source, not independent clinical evidence. Research access: 2026-10-24. History excerpt page 8: Ultraformer III (Shurink); Ultraformer MPT (Shurink Universe). These are naming statements, not proof every jurisdiction shares identical hardware, software, cartridges or indications.