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Plus AG605904A

by Inmode MD, Ltd.

Plus AG605904A (AS601654A) is a Class I device made by Inmode MD, Ltd., cleared under FDA 510(k) K153568 on 12 Jul 2016 and listed in FDA GUDID since 25 Oct 2016 (UDI-DI 07290016633245), 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) K153568

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 Number07290016633245 UDI-DI Date25 Oct 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK153568 Date12 Jul 2016DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153568 decided 12 Jul 2016 Active
  • FDA GUDID UDI-DI 07290016633245 listed 25 Oct 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153568
  2. Listed FDA GUDID 07290016633245

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Plus
Generic name
Radio-frequency skin surface treatment system
Model / Ref / Catalog
AG605904A, AS601654A
Primary DI / UDI-DI
07290016633245
510(k) Number
FDA product code
ISA, PBX
GMDN term
Radio-frequency skin surface treatment system
Device class
Class I
Regulation number
890.5660, 878.4400
GUDID distribution status
In Commercial Distribution

Similar devices in this category

Other devices filed under Radio-frequency skin surface treatment system.

Other devices from Inmode MD, Ltd.

See all devices from Inmode MD, Ltd. →

Properties

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