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InMode RF Multi-System AG606968A

by Inmode MD, Ltd.

InMode RF Multi-System AG606968A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K201150 on 22 Jul 2020 and listed in FDA GUDID since 26 Oct 2022 (UDI-DI 07290016633320), 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) K201150

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 Number07290016633320 UDI-DI Date26 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201150 Date22 Jul 2020DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201150 decided 22 Jul 2020 Active
  • FDA GUDID UDI-DI 07290016633320 listed 26 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201150
  2. Listed FDA GUDID 07290016633320

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
InMode RF Multi-System
Generic name
Percutaneous radio-frequency ablation system generator
Model / Ref / Catalog
AG606968A
Primary DI / UDI-DI
07290016633320
510(k) Number
FDA product code
GEI
GMDN term
Percutaneous radio-frequency ablation system generator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

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Properties

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