Identifiers
- 510(k) Number
- K250065 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
- Models / Variants
- DENSITY FDA 510(k)DENZA FDA 510(k)DENSITY Noir FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
DENSITY; DENZA; DENSITY Noir is an electrosurgical cutting and coagulation device. It is classified as a general, plastic surgery device under regulation number 21 CFR 878.4400.
The device was cleared via the FDA 510(k) pathway under K250065 with a traditional clearance type and a substantially equivalent decision. It is manufactured by Jeisys Medical Incorporated and received FDA clearance on July 8, 2025.
Frequently asked questions
What is the DENSITY Noir used for?
DENSITY Noir is an electrosurgical device designed for cutting and coagulation during surgical procedures. It is classified under general and plastic surgery applications, supporting tissue dissection and hemostasis.
How is the DENSITY Noir supplied?
The device is supplied by Jeisys Medical Incorporated, based in Seoul, South Korea. Contact information for the applicant is available through the manufacturer for procurement and technical support.
Is the DENSITY Noir sterile?
The device data does not specify whether DENSITY Noir is supplied sterile or non-sterile. Users should consult the manufacturer’s labeling or contact Jeisys Medical Incorporated for sterility status prior to use.
Is the DENSITY Noir single-use or reusable?
The device data does not explicitly state whether DENSITY Noir is single-use or reusable. This information must be verified with the manufacturer or product instructions for use to ensure proper handling and reprocessing.
What regulatory pathway was used for clearance?
DENSITY Noir was cleared via the FDA 510(k) premarket notification pathway under K250065. It received a substantially equivalent determination, indicating it is as safe and effective as a legally marketed predicate device.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: DENSITY; DENZA; DENSITY Noir (K250065) — FDA 510(k) | Innolitics, DENSITY Dental Materials | Medical Device Navigator, Jeisys | Product | DENSITY
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250065 | Class II | Active |
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Manufacturer
- Manufacturer
- Jeisys Medical Incorporated
Sources (1)
- FDA 510(k) K250065 24 fields · synced Sep 22, 2026