Device record questions
Model, accessory, jurisdiction and source role answer different device questions.
Use these distinctions when a commercial name, a clearance phrase or a recall headline leaves important conditions unstated.
Which conditions help answer lifting device questions?
The exact name and accessory establish the record; country and revision establish the document scope.
A source can answer one question while leaving another unresolved. A model match can coexist with an unverified Korean permit, and a named recall can concern specified tips rather than every console. Those combinations remain visible rather than being compressed into a single yes or no.
What else do people ask about lifting device questions?
Why does Oligio appear in several records?
Original Oligio, X and XM retain generation and energy distinctions supported by their own sources.
Can a brand name establish skin penetration?
A platform such as POTENZA has different applicator branches, so the exact tip is needed.
Is Shurink Universe a matched Korean permit?
The manufacturer naming relation to MPT is documented, and MFDS permit 제허21-831호 lists ULTRAFORMER MPT with SHURINK UNIVERSE.
Can one manufacturer’s indication be used for another device?
Each device keeps its own indications enclosure even when another device is used as a predicate.
Does a new body-area event apply to every old console?
Model, revision, accessory and jurisdiction conditions need their own document match.
Does a recall headline cover every product with that name?
A scoped record can name specific catalog numbers, tips and lots.
Does no match mean no safety issue?
No match means absence from the selected collection, not a complete safety assessment.
Can a specification establish the best device for my goal?
A technical value does not replace exact clinical endpoints, examination and personal consultation.
Are ratings combined into a device score?
No patient-rating aggregation or invented score is part of the model and document collection.
Where do these numbers come from?
- K243929 : Oligio X 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.
- K231287 : POTENZA 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.
- Class 2 Device Recall XERF EFFECTOR 60 Research access: 2026-10-24. Recall Z-0146-2026, affected catalog numbers/lots, firm-initiated 2025-09-04, posted 2025-10-14, displayed Open/Classified, manufacturing-defect reason and stop-use/return action. Applies to listed tips, not every XERF device.
- 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.
- 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.