Korea lifting device records

Find a lifting device by its exact model, energy and applicator, then read the source within its country and revision.

Oligio generations, surface RF, ultrasound and RF needle applicators retain separate records. Korean permit numbers come from MFDS item records; unmatched ones stay visibly unverified.

Lifting-device concept image with round and rectangular contact heads and teal wave lines

Which model are you looking for?

17 model / family records

Model or aliasManufacturerEnergyDocument jurisdiction

Check an applicator or another name

Known applicatorAnother name to check

Oligio / The OligioWON TECH Co., Ltd.Original Oligio; exact Korean legal model not matched
Energy / applicatorRadiofrequency (RF)Surface-contact applicator
DocumentsK221989 source, new tab WON-O source, new tab MFDS-PERMITS source, new tab
Korean permitMFDS 제허20-396호 (2020-05-28)
Oligio XWON TECH Co., Ltd.Oligio X; two verified US clearance events
Energy / applicatorRadiofrequency (RF)Surface-contact applicator
DocumentsK240313 source, new tab K243929 source, new tab WON-X source, new tab
Korean permitMFDS 제허23-860호 (2023-08-23)
Oligio XMWONTECH / 원텍 주식회사Korean marketed hybrid; exact regulatory model not matched
Energy / applicatorRF + ultrasoundMatch the applicator and IFU
DocumentsWON-XM source, new tab MFDS-PERMITS source, new tab
Korean permitMFDS 제허23-885호 (2023-09-01)The permit lists the product name oligio xm and the model field Oligio Kiss plus one more. That places both names in one permit record; it does not establish that every configuration is identical.
Thermage FLXSolta MedicalFLX; not CPT
Energy / applicatorRadiofrequency (RF)Surface-contact applicator
DocumentsK170758 source, new tab SOLTA-FLX source, new tab MFDS-PERMITS source, new tab
Korean permitMFDS 수허18-245호 (2018-08-21)Thermage CPT has a separate permit (수허13-687호).
VolnewmerCLASSYS Inc.Volnewmer; exact regional chassis/label pending
Energy / applicatorRadiofrequency (RF)Surface-contact applicator
DocumentsK240248 source, new tab CLASSYS-V source, new tab MFDS-PERMITS source, new tab
Korean permitMFDS 제허22-512호 (2022-08-01)
10THERMATentech Inc.FDA model TMSY02
Energy / applicatorRadiofrequency (RF)Surface-contact applicator
DocumentsK232992 source, new tab MFDS-PERMITS source, new tab
Korean permitMFDS 제허22-679호 (2022-10-11)The Korean model name (10THERMA-BK) differs from the US model TMSY02.
DENSITY (2023 record)Jeisys Medical Inc.Original FDA Density record K230663
Energy / applicatorRadiofrequency (RF)Surface-contact applicator
DocumentsK230663 source, new tab MFDS-PERMITS source, new tab
Korean permitMFDS 제허23-472호 (2023-04-05)
DENSITY / DENZA / DENSITY Noir (2025 record)Jeisys Medical IncorporatedThree trade names explicitly listed in FDA K250065; not three independent devices
Energy / applicatorRadiofrequency (RF)Surface-contact applicator
DocumentsK250065 source, new tab
Korean permitKorean permit unverifiedThe domestic DENSITY permit is 제허23-472호 (listed under the 2023 record). The DENSITY Noir permits found (제허23-63호, 제허24-114호) are export-only, and no DENZA permit was found, so the three-name 2025 record is not matched.
POTENZAJeisys Medical Inc.K231287 update: S handpiece plus three noninvasive tips
Energy / applicatorRadiofrequency (RF)Match the applicator and IFUSelect a tip to distinguish skin penetration.
DocumentsK231287 source, new tab MFDS-PERMITS source, new tab
Korean permitMFDS 제허19-78호 (2019-01-29)Other POTENZA records (제허19-126호, 제허25-497호) are export-only. Tip electrodes are separate permits.
XERFLutronic CorporationXERF K251327; exact Korea model pending
Energy / applicatorRadiofrequency (RF)Surface-contact applicator
DocumentsK251327 source, new tab XERF-OEM source, new tab MFDS-PERMITS source, new tab
Korean permitMFDS 제허24-6호 (2024-01-03); MFDS 제허26-350호 (2026-05-11)Two domestic permits carry the XERF name; which one matches a given installed unit needs its label. XERF I and XERF-Overseas permits are export-only.
Forma / Plus handpiecesInMode Ltd.Forma/Plus as configured on Optimas MAX; separate applicators
Energy / applicatorRadiofrequency (RF)Surface-contact applicator
DocumentsK251632 source, new tab INMODE-FORMA source, new tab
Korean permitKorean permit unverifiedThe InMode RF import permit found (수허19-352호, model name Inmode RF) does not name Forma, so it is not matched.
Morpheus8 applicator familyInMode Ltd.Morpheus8 applicators K231790; Optimas MAX configuration K251632; Burst/Cool branding is not automatic regulatory equivalence
Energy / applicatorRadiofrequency (RF)Penetrating electrodes
DocumentsK231790 source, new tab K251632 source, new tab INMODE-M8 source, new tab
Korean permitKorean permit unverifiedThe InMode RF import permit found (수허19-352호, model name Inmode RF) does not name Morpheus8, so it is not matched.
Ulthera System / Ultherapy (legacy IFU)Ulthera, Inc.Legacy control-unit IFU, 1015107IFU Rev 05
Energy / applicatorUltrasoundSurface-contact applicator
DocumentsULTHERA-IFU source, new tab MFDS-PERMITS source, new tab
Korean permitMFDS 수허09-1024호 (2009-10-13)One permit lists both Ulthera system and Ulthera Prime.
Ulthera System PRIMEUlthera, Inc.UC-1 Control Unit PRIME K233996; PRIME Model 2.1 K250418 kept as model revision
Energy / applicatorUltrasoundSurface-contact applicator
DocumentsK233996 source, new tab K250418 source, new tab K260618 source, new tab
Korean permitMFDS 수허09-1024호 (2009-10-13)One permit lists both Ulthera system and Ulthera Prime.
ULTRAFORMER IIICLASSYS Inc.ULTRAFORMER III; distinct from MPT
Energy / applicatorUltrasoundSurface-contact applicator
DocumentsCLASSYS-III source, new tab CLASSYS-ALIASES source, new tab MFDS-PERMITS source, new tab
Korean permitMFDS 제허14-1422호 (2014-08-01)The ULTRAFORMER III UF3-C300 permit (제허19-201호) is export-only.
ULTRAFORMER MPTCLASSYS Inc.MPT = Micro-Pulsed Technology; distinct from III
Energy / applicatorUltrasoundSurface-contact applicator
DocumentsCLASSYS-MPT source, new tab CLASSYS-ALIASES source, new tab MFDS-PERMITS source, new tab
Korean permitMFDS 제허21-831호 (2021-10-06)ULTRAFORMER MPT PLUS has a separate permit (제허26-208호).
SofWave System / SUPERBSofwave Medical Ltd.SUPERB ultrasound; Pure Impact is a separate electrical muscle-stimulation module
Energy / applicatorUltrasoundSurface-contact applicator
DocumentsK233104 source, new tab K250146 source, new tab SOF-TECH source, new tab
Korean permitMFDS 수허21-183호 (2021-07-22)

Research snapshot 2026-10-24; Korean permit numbers matched against MFDS item records on 2026-10-25. Not a list of Korean sales or installations. Inputs stay in browser memory.

How do consoles and tips differ?

A platform may support both penetrating and surface-contact tips. Keep the model, applicator and source together.

Open model and applicator finder

What is the document’s scope?

Distinguish US records, Korean MFDS permits and specified-tip recalls. The tool does not choose a treatment.

Open document scope checker

Which records should you read first?

Lifting device types in Korea
Exact model, generation and applicator identify a device more precisely than its brand name alone.
Lifting energy types in Korea
RF, focused ultrasound and parallel-beam ultrasound describe different delivery architectures, with applicator-specific boundaries.
Lifting authorization checks
A regulatory claim needs its own jurisdiction, exact model and indications document.
Device source provenance
A source’s role and the extent actually read determine which device statements it can support.

How are lifting devices grouped by energy and delivery?

Energy family and applicator delivery distinguish surface RF, RF needles, ultrasound and documented combinations.

A shared lifting label does not identify one mechanism. Surface contact and skin penetration are separate fields, and a platform can support both kinds of accessory. The source for each model shows which configuration was actually described.

Energy and applicator families
Family	Documented example	Distinction
Surface RF	Oligio X / Thermage FLX	Model-specific indications
RF accessories	POTENZA / Morpheus8	Needle or surface tip
Ultrasound	Ulthera / ULTRAFORMER / Sofwave	Focused, imaging and parallel architecture

Why do lifting device names need a generation?

A shared brand can cover different models, while several names can also appear in one document.

Oligio, X and XM remain separate records. DENSITY, DENZA and DENSITY Noir are read as names listed in one selected US document. Manufacturer naming statements support Shurink relationships without proving every local configuration identical.

What do lifting device source documents establish?

A source can establish identity, technical description or a selected regulatory event within its own scope.

The FDA indications enclosure belongs to the named device and jurisdiction. A manufacturer page has a different role from an independent clinical study. Reading those roles separately prevents a technical specification from becoming a promise of personal benefit.

Three source roles
Source	Read for	Do not substitute
Regulator record	Model, country and stated indication	Current Korean permit from US evidence
Manufacturer document	Product name and technical claim	Independent clinical comparison
Original study	Studied model, endpoint and population	Every model with the same energy

What is the scope of the lifting device collection?

The 2026-10-24 collection contains 17 model or family records and 18 unique selected US 510(k) documents.

These are collection counts rather than all authorized or installed devices. Current Korean product permits and local labels have not been matched. The missing fields are preserved rather than filled from an overseas identifier.

How do you read device documents?

What else do people ask about Korea lifting device records?

Where should I start with a name on a quote?

Use the model finder, then match the actual handpiece or tip and the source document.

Can I compare RF and ultrasound as one ranking?

Their architectures, indications and studied endpoints need separate evidence.

Why is Korean permit status unverified?

This research has not matched current domestic permit text and exact local labels.

Does the record list recommend a clinic or device?

It supports source identification without booking, referral or personal treatment selection.

Can I read the same content in Korean?

Each static English route has a Korean counterpart under /ko. Server blog posts remain Korean.

Where do these numbers come from?

K243929 : Oligio X · US FDA 510(k) clearance (United States) · U.S. Food and Drug Administration · Primary source 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 · US FDA 510(k) clearance (United States) · U.S. Food and Drug Administration · Primary source 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.
Ulthera System Instructions for Use : 1015107IFU Rev 05 · Manufacturer material (not a permit) · Ulthera : US instructions for use · Primary source Manufacturer first-party identity/technical source, not independent clinical evidence. Research access: 2026-10-24. Sections 2.1 indications and DeepSEE imaging, system identity. Only these selected sections; not the entire 72-page manual.
의료기기안심책방 · Korea MFDS portal entry page · Ministry of Food and Drug Safety · Primary source 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.
Medical device item search (의료기기안심책방): lifting device permits · Korea MFDS product permit records (Korean authorization) · Ministry of Food and Drug Safety · Primary source 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.