Korea Sofwave modules
Sofwave SUPERB ultrasound and the Pure Impact electrical muscle-stimulation module have separate delivery and intended-use records.
The selected SofWave System documents contain more than one module. A skin-laxity statement and a muscle-training statement belong to different parts of the system even when they share a console name.
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Which Sofwave modules must be separated?
The ultrasound applicator and Pure Impact electrical muscle stimulation retain separate technology and indication fields.
The system name can appear in both portions of a submission. To understand a claim, identify whether the source refers to ultrasound or to the muscle module. A shared console does not establish identical energy, target tissue or evidence. The catalog records the ultrasound model while explaining the separate module relationship.
| Exact record | Energy family | Verified US document and event date | Korean MFDS permit |
|---|---|---|---|
| SofWave System / SUPERB | Ultrasound | K233104 (2023-12-22); K250146 (2025-04-18) | MFDS 수허21-183호 (2021-07-22) |
Is Sofwave SUPERB the same architecture as focused HIFU?
The manufacturer describes parallel-beam ultrasound, which is kept distinct from focused ultrasound and RF.
The regulatory classification name can use focused-ultrasound terminology while the device-description table describes a high-intensity non-focused ultrasound module. The detailed delivery description therefore matters more than treating one classification label as a complete physical diagram. This distinction does not establish a comparative lifting outcome.
| Module | Documented delivery | Scope retained |
|---|---|---|
| SUPERB / ultrasound applicator | Ultrasound; manufacturer describes parallel beams | Own aesthetic indication wording |
| Pure Impact | Electrical muscle stimulation | Healthy-muscle conditioning and training wording |
| Shared system name | Console-level identity | Does not merge tissue targets or outcomes |
What skin scope appears in the selected Sofwave documents?
The selected US records preserve their own facial, specified lifting, scar and upper-arm appearance wording.
K233104 and K250146 are read as specific events rather than a universal list of every possible skin use. The listed body areas and age conditions belong to the actual indications enclosure. Regulatory wording does not predict the amount of change for an individual or prove superiority over another ultrasound architecture.
What does the Pure Impact wording describe?
The selected submission describes stimulation of healthy muscles to improve or facilitate muscle performance.
The module has its own muscle-tone, strengthening and training descriptions. These are not assigned to the ultrasound handpiece, and the document says the muscle module is not intended for treatment of medical diseases or conditions. The source identifies a separate device function; it does not establish a personal exercise or rehabilitation recommendation.
How should a Sofwave depth claim be interpreted?
A manufacturer thermal-zone description remains a technical claim and does not set an individual treatment depth.
A thermal zone, a transducer specification and the tissue assessed in a study are different measurements. Converting a technical description directly into a rule for choosing a procedure would skip those distinctions. The model record keeps the delivery source visible and leaves personal suitability to a clinical assessment outside the tool.
Do Sofwave manufacturer pages and studies provide the same evidence?
A manufacturer page identifies a technical claim, while a study retains its own model, site, endpoint and follow-up.
A study of the face is not silently replaced with a study of upper arms, and an observation of volume is not a direct fat-destruction claim. The device catalog is designed to help locate the exact model source, not to merge every result attached to the commercial name. That separation also prevents muscle-module outcomes being used as ultrasound skin evidence.
Which Sofwave checks remain before a Korean configuration is confirmed?
The exact Korean system, module label, current permit and amendments remain unmatched in the research snapshot.
A US clearance does not fill the domestic permit field. The current source collection also does not claim to list every subsequent change or all safety events. The model finder and document checker can disclose the selected records without concluding that an absent event or missing field proves authorization, absence of risk or local availability.
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 Sofwave modules?
Is Pure Impact another name for SUPERB?
The records distinguish an electrical muscle-stimulation module from the ultrasound module.
Can the muscle indication be assigned to ultrasound?
Each module retains its own intended-use wording.
Does parallel ultrasound mean every HIFU device is equivalent?
The architecture and model-specific evidence remain separate.
Can a body-area study establish a facial result?
The original study site and endpoint must remain attached to its result.
Does the US record establish current Korean sale?
Domestic permit and market status require their own matched records.
Where do these numbers come from?
- K233104 : SofWave System 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.
- K250146 : SofWave System 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.
- Sofwave SUPERB Technology Manufacturer first-party identity/technical source, not independent clinical evidence. Research access: 2026-10-24. SUPERB parallel ultrasound architecture and cooling; manufacturer specifies thermal zone 0.5–2 mm centered at 1.5 mm. Safety absolutes and comparative claims not adopted.
- Evaluating the Use of High-Intensity Non-Focused Ultrasound Treatment to Improve Skin Laxity and Facial Wrinkles in Asian Patients Research access: 2026-10-24. Original PubMed/Europe PMC abstract, original PMC indexed introduction/limitations/acknowledgments excerpts. Direct PMC full text blocked; Europe PMC fullTextXML unavailable. NOT full-text verified. PubMed issue date is October 2026; MED first-publication date is June 1, 2026. Link recheck on 2026-10-25 did not return HTTP 200; earlier reading extent is retained.
- A Single-Center, Blinded, Split-Body, Randomized Clinical Trial of High-Intensity, Parallel Ultrasound Beams Versus Microfocused Ultrasound With Visualization for the Treatment of Upper Inner Arm Skin Laxity Research access: 2026-10-24. Complete PubMed abstract, metadata; issue date 2026-04-01. Full text/COI not obtained. Link recheck on 2026-10-25 did not return HTTP 200; earlier reading extent is retained.
- 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.