Skip to content

Agnes-S

by Agnes Medical Co., Ltd.

Agnes-S is a Class II device made by Agnes Medical Co., Ltd., cleared under FDA 510(k) K203013 on 14 Jul 2022 and listed in FDA GUDID since 14 Jul 2023 (UDI-DI 18800067700016), 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) K203013

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 Number18800067700016 UDI-DI Date14 Jul 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK203013 Date14 Jul 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K203013 decided 14 Jul 2022 Active
  • FDA GUDID UDI-DI 18800067700016 listed 14 Jul 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K203013
  2. Listed FDA GUDID 18800067700016

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Intradermal radio-frequency ablation system
Model / reference
AGNES-S
Primary DI / UDI-DI
18800067700016
510(k) Number
FDA product code
GEI, KCW
GMDN term
Intradermal radio-frequency ablation system
Device class
Class II
Regulation number
878.4400, 878.5350
GUDID distribution status
In Commercial Distribution

Related devices

Category: Intradermal radio-frequency ablation system

Cleared under the same submission (K203013)

Similar devices

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

Other devices from Agnes Medical Co., Ltd.

  • PlazMagik

    Class II

  • Ro-25S

    Class II

  • Ro-25D

    Class II

  • Ro-25S(G)

    Class II

See all devices from Agnes Medical Co., Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)