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EmPowerRF platform AG609933A

by Inmode MD, Ltd.

EmPowerRF platform AG609933A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K210492 on 12 Jul 2021 (1 earlier submission) and listed in FDA GUDID since 25 Oct 2022 (UDI-DI 07290016633702), 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

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07290016633702 UDI-DI Date25 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK210492 Date12 Jul 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K210492 decided 12 Jul 2021 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07290016633702 listed 25 Oct 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201150
  2. Cleared FDA 510(k) K210492
  3. Listed FDA GUDID 07290016633702

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
EmPowerRF platform
Generic name
Multi-modality skin surface treatment system
Model / Ref / Catalog
AG609933A
Primary DI / UDI-DI
07290016633702
510(k) Number
FDA product code
GEI, PBX, ISA, NUV
GMDN term
Multi-modality skin surface treatment system
Device class
Class II
Regulation number
878.4400, 890.5660, 878.4810
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multi-modality skin surface treatment system

Cleared under the same submission (K201150)

and 1 more cleared under K201150

Cleared under the same submission (K210492)

and 6 more cleared under K210492

Similar devices in this category

Other devices filed under Multi-modality 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)