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Morpheus8 90 Applicator AG613133A

by Inmode MD, Ltd.

Morpheus8 90 Applicator AG613133A is a Class II device made by Inmode MD, Ltd., cleared under FDA 510(k) K240017 on 13 Jun 2024 and listed in FDA GUDID since 19 Apr 2026 (UDI-DI 07290019863205), 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) K240017

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 Number07290019863205 UDI-DI Date19 Apr 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK240017 Date13 Jun 2024DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K240017 decided 13 Jun 2024 Active
  • FDA GUDID UDI-DI 07290019863205 listed 19 Apr 2026 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K240017
  2. Listed FDA GUDID 07290019863205

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Morpheus8 90 Applicator
Generic name
Radio-frequency skin surface treatment system applicator
Model / Ref / Catalog
AG613133A
Primary DI / UDI-DI
07290019863205
510(k) Number
FDA product code
GEI
GMDN term
Radio-frequency skin surface treatment system applicator
Device class
Class II
Regulation number
878.4400
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K240017)

Similar devices

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

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)