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DENSITY Tip High-F Tip

by Jeisys Medical Incorporated 2 variants

DENSITY Tip High-F Tip is a Class II device made by Jeisys Medical Incorporated, cleared under FDA 510(k) K250065 on 8 Jul 2025 and listed in FDA GUDID since 16 Mar 2026 (UDI-DI 08800020108388), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K250065

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800020108388 UDI-DI Date16 Mar 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK250065 Date8 Jul 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K250065 decided 8 Jul 2025 Active
  • FDA GUDID UDI-DI 08800020108388 listed 16 Mar 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K250065
  2. Listed FDA GUDID 08800020108388

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
DENSITY Tip
Generic name
Radio-frequency skin/body contouring system
Model / reference
High-F Tip
Primary DI / UDI-DI
08800020108388
510(k) Number
FDA product code
GEI
GMDN term
Radio-frequency skin/body contouring system
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K250065)

and 8 more cleared under K250065

Similar devices

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

Other devices from Jeisys Medical Incorporated

  • INTRAcel Tip 3

    Class II

  • INTRAcel Tip 1010

    Class II

  • INTRAcel Tip 1012

    Class II

  • POTENZA Tip CP-21 TIP

    Class II

See all devices from Jeisys Medical Incorporated →

Properties

  • Single use
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)