Manufacturer
Jeisys Medical IncorporatedDENSITY; DENZA; DENSITY Noir
Country / Region:Korea, Republic of (KR)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250065
- Device name
- DENSITY; DENZA; DENSITY Noir
- Company
- Jeisys Medical Incorporated
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2025-01-10
- Decision date
- 2025-07-08
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for Use
This device indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Intended Use
This device indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
The DENSITY, DENZA, DENSITY Noir generates radiofrequency (RF) energy by means of high RF at 6.78MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. In detail, the main body uses the 'reverse thermal gradient' principle to deliver RF energy, and thus, heat is generated and selective coagulation occurs while cooling the epidermis, resulting in denaturation and contraction of collagen fibers. The devices are an RF (radiofrequency), software-controlled electrosurgical device used for electrocoagulation of soft tissue and hemostasis. It consists of the following components: • Electrosurgical Unit - Main body • Handpiece • electrode tips • Neutral electrode pad and neutral electrode pad cable, cleared under K201685 • Foot switch • Power cord.
Summary parsed at:2026-06-20 17:55:03 UTC