Device label and record
Ask to see the system label or a legible photo. Compare the model, approval number, manufacturer or importer, and standard code with the relevant entry in the MFDS medical device database (accessed 18 October 2026). The search offers name and UDI-code fields. Use the details on the label to find the record, then ask the clinic to explain any mismatch.
| Question | What the answer helps you check |
|---|---|
| What is the exact system model? | Whether the quote, label and public record identify the same model. |
| Which Korean record applies to this system? | The approval number, company details and intended use in the record the clinic identifies. |
| Can you explain a different name or code? | Whether the clinic can account for a discrepancy rather than relying on a familiar brand name. |
| Who can confirm the supply history of this machine? | Where to direct a question about the particular system, using its manufacturing or serial number. |
A public product record describes the listed product. It does not establish the supply history or condition of the individual machine in the room. If the explanation leaves a question unresolved, ask the manufacturer or importer identified in the record before proceeding.
Applicator information
Ask what the clinic means by “tip” and for the exact applicator name. The US FDA 510(k) summary K250146 for the SofWave System names Lift, Precise and Smooth/LiftHD applicators (page 7, accessed 18 October 2026). That US document is a reference for those names, not confirmation of the Korean documentation or provenance of an applicator shown at a clinic.
- Which applicator will be used for the area in my plan?
- Can I see its name and how it connects to the system before treatment?
- Which Korean documentation covers this system and applicator combination?
- Can you include the applicator name in the treatment documentation?
Treatment documentation
Before treatment, ask for a quote that names the device and planned areas. Ask what record you can obtain afterwards, how to request it and whether it can include the device, applicator, treated areas, treatment date and amount of treatment.
The quote records the proposal; the treatment record documents what the clinic records as performed. Neither is an independent authenticity certificate. Keep them with the aftercare instructions and the contact details for questions.
Questions for the consultation
Bring any unresolved model or applicator questions to the consultation. Ask who will explain the proposed treatment and who will answer documentation questions afterwards. The consultation question checklist covers the wider treatment plan.
Does a matching MFDS record prove that a machine is genuine?
No. It lets you compare the label information with a public product record. Questions about a particular machine’s supply history need an answer from the clinic, manufacturer or importer.
Does a system search settle which applicator is covered?
Ask for the documentation covering the named system and applicator combination. A brand-name search alone does not settle that question.
Can FDA paperwork replace a Korean device-record check?
No. The FDA summary describes a US regulatory submission. Ask the clinic for the Korean record relevant to the system and applicator it plans to use.