Korea surface RF devices
Surface RF records separate circuit, applicator and document scope rather than treating all RF brands as equivalent.
Thermage FLX, Volnewmer, 10THERMA, DENSITY and XERF share an RF label but retain different device and indication records. Source descriptions identify the system; they do not select a treatment.
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Which surface RF device records can be compared?
The table compares selected identity and US event records, not the full Korean market.
The records retain the exact submitted names. DENSITY has an original and an expanded-name record, while Thermage FLX is kept apart from CPT. The list is useful for checking which document belongs to a name on a quotation, but inclusion does not mean a device is marketed or authorized in Korea.
| Exact record | Energy family | Verified US document and event date | Korean MFDS permit |
|---|---|---|---|
| Thermage FLX | Radiofrequency | K170758 (2017-09-22) | MFDS 수허18-245호 (2018-08-21) |
| Volnewmer | Radiofrequency | K240248 (2024-04-29) | MFDS 제허22-512호 (2022-08-01) |
| 10THERMA | Radiofrequency | K232992 (2023-12-20) | MFDS 제허22-679호 (2022-10-11) |
| DENSITY (2023 record) | Radiofrequency | K230663 (2023-08-14) | MFDS 제허23-472호 (2023-04-05) |
| DENSITY / DENZA / DENSITY Noir (2025 record) | Radiofrequency | K250065 (2025-07-08) | Korean permit unverified |
| XERF | Radiofrequency | K251327 (2025-08-11) | MFDS 제허24-6호 (2024-01-03); MFDS 제허26-350호 (2026-05-11) |
How are monopolar and bipolar RF records separated?
The circuit description and electrode arrangement are separate fields from the product name.
The selected Thermage FLX, Volnewmer, 10THERMA and XERF records describe monopolar RF. DENSITY documents describe monopolar and bipolar operation. A circuit label does not express a universal treatment depth, tissue response or superiority. Those claims require their own matched evidence.
| Axis | Recorded field | Not inferred |
|---|---|---|
| Circuit | Monopolar, bipolar or documented combination | Universal tissue effect |
| Accessory | Exact surface electrode and cooling description | Interchangeable tip |
| US indication | Own enclosure for the device | Indication inherited from a predicate |
Do surface RF documents all state lifting indications?
Several selected documents state electrocoagulation and hemostasis; Thermage FLX has its own mode-specific list.
The words on the enclosure control the regulatory summary. A comparison table that names a wrinkle device does not give the subject device every wrinkle use of that predicate. A consumer-facing lifting category therefore remains a search label, while the document summary preserves the narrower language.
Why does the surface RF tip matter?
The tip, cooling and return-path descriptions belong to the documented configuration.
A platform may use several surface electrodes with different labels and technical descriptions. A new tip list in a later submission is evidence of that document’s configuration, not proof that all earlier or local consumables can be substituted. The quotation should distinguish console and accessory names before specifications are compared.
Can RF frequency or power rank these devices?
Frequency and power are technical observations whose units, circuits and operating conditions must stay attached.
A maximum rating may be described differently from an operating condition. Different electrodes and modes also prevent a raw number from representing identical exposure. The catalog preserves documented specifications and unresolved conflicts, without converting them to a stronger or safer device score.
How is a surface RF safety event scoped?
A recall must be matched to its named accessory, catalog number, lot and jurisdiction.
The selected XERF event concerns specified EFFECTOR60 tips. That is different from declaring every console and tip recalled. Likewise, an FDA communication about certain RF microneedling uses concerns a penetrating exposure and cannot automatically be attached to every surface RF system.
What can the surface RF list support?
It supports source matching and questions about the exact device, not treatment or clinic selection.
The record can reveal a missing model suffix, an absent accessory name or a US-only indication. The next useful evidence may be a current local permit, an instruction revision or a study conducted with the same configuration. Those are distinct records and should not be filled by brand familiarity.
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 Surface RF records?
Is this a Korean approved-device list?
No. It lists MFDS permit numbers for 14 of 17 records matched by product or model name; it is not a full list of Korean authorized devices.
Is every RF device noninvasive?
No. These are surface records; RF microneedling is a separate applicator-dependent exposure.
Does FLX include CPT?
The two model names are kept separate when matching documents and studies.
Do equal shots mean equal exposure?
Different tips, circuits and conditions prevent that assumption.
Does an absent recall mean no safety issue?
The catalog is not an exhaustive recall or adverse-event history.
Where do these numbers come from?
- K170758 : Thermage FLX System and Accessories 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.
- K240248 : Volnewmer 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.
- K232992 : 10THERMA 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.
- K230663 : Density 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.
- K250065 : DENSITY; DENZA; DENSITY Noir 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.
- K251327 : Xerf 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.
- VOLNEWMER - CLASSYS Manufacturer first-party identity/technical source, not independent clinical evidence. Research access: 2026-10-24. 6.78 MHz monopolar RF; continuous water/contact cooling; four tip types. The page says FDA approval; this catalog normalizes the verified event to 510(k) clearance.
- XERF - Structural Skin Tightening - Cynosure Lutronic Manufacturer first-party identity/technical source, not independent clinical evidence. Research access: 2026-10-24. Multifrequency monopolar RF, 2 and 6.78 MHz, cooling; US intended-use footer. No-numbing/no-downtime guarantees not adopted.
- 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.
- Potential Risks with Certain Uses of Radiofrequency (RF) Microneedling : FDA Safety Communication Research access: 2026-10-24. Full substantive communication, recommendations, device description, FDA actions/reporting read (web lines 52–85).
- 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.