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Morpheus8 Applicator AG607401A

by Inmode MD, Ltd.

Ref AG607401A

Morpheus8 Applicator AG607401A is a device classified as Class IIb in the EU and Class II in the US made by Inmode MD, Ltd., registered in EUDAMED on 27 May 2026 (Basic UDI-DI B-07290016633412), cleared under FDA 510(k) K200947 on 2 Jul 2020 (1 earlier submission) and listed in FDA GUDID since 31 Oct 2022 (UDI-DI 07290016633412), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K200947

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07290016633412 Basic UDI-DI 07290016633412UDI-DIDate27 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016633412 UDI-DI Date31 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK200947 Date2 Jul 2020DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290016633412 registered 27 May 2026 Active
  • FDA 510(k) K200947 decided 2 Jul 2020 Active· +1 more in the status table
  • FDA GUDID UDI-DI 07290016633412 listed 31 Oct 2022 Listed

Timeline

4 dated events

  1. Cleared FDA 510(k) K192695
  2. Cleared FDA 510(k) K200947
  3. Listed FDA GUDID 07290016633412
  4. Registered EUDAMED B-07290016633412

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Morpheus8 Applicator
Generic name
Radio-frequency skin surface treatment system applicator
Device name
Morpheus8 Bipolar Radiofrequency Applicator
Model / Ref / Catalog
AG607401A
Primary DI / UDI-DI
07290016633412
Basic UDI-DI
B-07290016633412
510(k) Number
FDA product code
GEI
EMDN code
Z12040218 Endermology treatments
GMDN term
Radio-frequency skin surface treatment system applicator
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
878.4400
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Radio-frequency skin surface treatment system applicator

Cleared under the same submission (K192695)

and 1 more cleared under K192695

Cleared under the same submission (K200947)

Similar devices in this category

Other devices filed under GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS.

Other devices from Inmode MD, Ltd.

See all devices from Inmode MD, Ltd. →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)