Korea DENSITY names
DENSITY, DENZA and DENSITY Noir appear together in one verified US submission, while the earlier DENSITY record remains separate.
Names on a manufacturer advertisement and names in a US submission answer different questions. The shared-name record supports identification, while local labels and consumables still require their own match.
On this page
Which DENSITY records are kept apart?
The original DENSITY submission and the later three-name submission are separate regulatory records.
A new document can change the listed names or accessory configuration without creating three unrelated consoles. The comparison keeps each event identifier and the wording used in that event. It does not infer Korean product launch dates from the order of US decisions.
| Exact record | Energy family | Verified US document and event date | Korean MFDS permit |
|---|---|---|---|
| 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 |
What does the shared DENSITY DENZA record establish?
The verified document explicitly lists the three trade names together for that submission.
This establishes a documentary relationship, not universal interchangeability of all products sold under those names. A local label may identify a particular version or consumable. Matching that label remains necessary before applying the record to a particular device.
| Record | What it establishes | Still unresolved |
|---|---|---|
| K230663 | Original DENSITY identity | Later-name/local configuration |
| K250065 | DENSITY / DENZA / DENSITY Noir listed together | Every local label or tip is identical |
| Clinical DENSITY paper | Model and procedure in that study | Every named generation has equal results |
How does the DENSITY circuit description help?
The documents describe monopolar and bipolar RF and preserve configuration-specific technical details.
A combined circuit description identifies how the system is described to operate. It does not quantify an individual’s lifting response or prove superiority over a single-circuit device. A sequential technique in a paper also needs the study’s model, accessory and protocol to remain attached.
Why is the DENSITY tip list kept with its document?
A later submission’s tip list belongs to the configuration described in that submission.
The later record describes an expanded tip list. A matching trade name alone does not establish that a clinic’s consumable is one of those entries. Tip labels and the current local instructions remain the relevant evidence for a specific configuration, including compatibility and permitted use.
Do the DENSITY records establish Korean lifting authorization?
The verified US records describe electrocoagulation and hemostasis; current Korean permits remain unmatched.
The US indications enclosure sets the scope of that regulatory summary. Marketing terms or a shared predicate cannot expand it. The domestic permit field holds only a matched MFDS record, and a missing permit match is not a finding that the device is unauthorized or unavailable.
Can one DENSITY study cover every related name?
A study remains attached to its reported device and procedure, even when a later regulatory record lists related names.
The selected DENSITY clinical record is an uncontrolled case series with its own model and technique description. Its observations do not create a direct comparison between original and later-name products. Regulatory identity and clinical outcomes are different evidence relationships.
Which DENSITY source limits remain visible?
Blocked manufacturer pages, unmatched domestic labels and selected-section review remain explicit limitations.
Current Jeisys product-page retrieval failed during the research. The device and US-use statements therefore rely on the directly read regulator documents. An error page is not a technical source. The model finder can identify the shared-name document while continuing to display the missing local match.
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 DENSITY names?
Are DENSITY, DENZA and Noir counted as three devices?
The shared submission lists three trade names; it is not counted as three unrelated devices.
Does a shared name prove tip interchangeability?
No. The current model label, tip and instructions still need matching.
Did the research read the current Jeisys product page?
Retrieval was blocked; the US statements rely on regulator documents.
Does a case series compare generations?
It preserves the model studied; it does not compare every related generation.
Is the US event the Korean release date?
The date belongs to the US decision, not verified Korean distribution.
Where do these numbers come from?
- 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.
- The Safety and Efficacy of the Mono‐Bi CrossLIFT Technique Utilizing Capacitive‐Coupled Sequential Monopolar and Bipolar Pulsed Radiofrequency for Simultaneous Facial Skin Tightening and Contouring: A Clinical Case Series Research access: 2026-10-24. Original XML: abstract, design/device excerpts, full Results, limitations and COI read. No full graphic/figure audit; no explicit funding statement located.
- 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.