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DENSITY - DENSITY

by Jeisys Medical Incorporated

510(k) K250065

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK250065 Date8 Jul 2025ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
GEI
Models / Variants
DENSITY
Device class
Class II
Regulation
21 CFR Part 878.4400
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 22 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K250065

22 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K250065
UDI-DISize and differences
Density B-Tip
Jeisys Medical Incorporated
Density B-Tip08800020104250
Prescription: yes; Single use: yes
On the market
Density B-Tip II
Jeisys Medical Incorporated
Density B-Tip II08800020104243
Prescription: yes; Single use: yes
On the market
Density F-Tip
Jeisys Medical Incorporated
Density F-Tip08800020104267
Prescription: yes; Single use: yes
On the market
Density F-Tip II
Jeisys Medical Incorporated
Density F-Tip II08800020104274
Prescription: yes; Single use: yes
On the market
DENSITY Foot switch
Jeisys Medical Incorporated
Foot switch08800020108166
Prescription: no; Single use: no
On the market
DENSITY Handpiece DT-HP-01
Jeisys Medical Incorporated
DT-HP-0108800020107626
Prescription: no; Single use: no
On the market
Density I-Tip
Jeisys Medical Incorporated
Density I-Tip08800020104229
Prescription: yes; Single use: yes
On the market
Density I-Tip II
Jeisys Medical Incorporated
Density I-Tip II08800020104236
Prescription: yes; Single use: yes
On the market
Density Main body
Jeisys Medical Incorporated
Density Main body08800020104304
Prescription: yes; Single use: no
On the market
DENSITY Tip ALPHA TIP
Jeisys Medical Incorporated
ALPHA TIP08800020106827
Prescription: no; Single use: yes
On the market
DENSITY Tip Classic-B Tip
Jeisys Medical Incorporated
Classic-B Tip08800020108333
Prescription: no; Single use: yes
On the market
DENSITY Tip Classic-B Tip
Jeisys Medical Incorporated
Classic-B Tip08800020104984
Prescription: no; Single use: yes
On the market
DENSITY Tip Classic-E Tip
Jeisys Medical Incorporated
Classic-E Tip08800020104991
Prescription: no; Single use: yes
On the market
DENSITY Tip Classic-E Tip
Jeisys Medical Incorporated
Classic-E Tip08800020108340
Prescription: no; Single use: yes
On the market
DENSITY Tip Classic-F Tip
Jeisys Medical Incorporated
Classic-F Tip08800020105004
Prescription: no; Single use: yes
On the market
DENSITY Tip Classic-F Tip
Jeisys Medical Incorporated
Classic-F Tip08800020108357
Prescription: no; Single use: yes
On the market
DENSITY Tip High-B Tip
Jeisys Medical Incorporated
High-B Tip08800020105059
Prescription: no; Single use: yes
On the market
DENSITY Tip High-B Tip
Jeisys Medical Incorporated
High-B Tip08800020108364
Prescription: no; Single use: yes
On the market
DENSITY Tip High-E Tip
Jeisys Medical Incorporated
High-E Tip08800020108371
Prescription: no; Single use: yes
On the market
DENSITY Tip High-E Tip
Jeisys Medical Incorporated
High-E Tip08800020105066
Prescription: no; Single use: yes
On the market
DENSITY Tip High-F Tip
Jeisys Medical Incorporated
High-F Tip08800020108388
Prescription: no; Single use: yes
On the market
DENSITY Tip High-F Tip
Jeisys Medical Incorporated
High-F Tip08800020105073
Prescription: no; Single use: yes
On the market

Similar devices

Other devices filed under FDA product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

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