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Morpheus8 TIP AG607563A

by Inmode MD, Ltd.

Ref AG607563A

Morpheus8 TIP AG607563A is a device classified as Class IIa in the EU and Class II in the US made by Inmode MD, Ltd., registered in EUDAMED on 28 May 2026 (Basic UDI-DI B-07290016633443), cleared under FDA 510(k) K221571 on 30 Jun 2022 (4 earlier submissions) and listed in FDA GUDID since 23 Jan 2023 (UDI-DI 07290016633443), 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) K221571

+4 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-07290016633443 Basic UDI-DI 07290016633443UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07290016633443 UDI-DI Date23 Jan 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK221571 Date30 Jun 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07290016633443 registered 28 May 2026 Active
  • FDA 510(k) K221571 decided 30 Jun 2022 Active· +4 more in the status table
  • FDA GUDID UDI-DI 07290016633443 listed 23 Jan 2023 Listed

Timeline

7 dated events

  1. Cleared FDA 510(k) K192695
  2. Cleared FDA 510(k) K200947
  3. Cleared FDA 510(k) K201150
  4. Cleared FDA 510(k) K210492
  5. Cleared FDA 510(k) K221571
  6. Listed FDA GUDID 07290016633443
  7. Registered EUDAMED B-07290016633443

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  • Withdrawn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 TIP
Generic name
Radio-frequency skin contouring system applicator tip
Device name
Morpheus8 24pin Tip
Model / Ref / Catalog
AG607563A
Primary DI / UDI-DI
07290016633443
Basic UDI-DI
B-07290016633443
510(k) Number
FDA product code
GEI
EMDN code
Z12040218 Endermology treatments
GMDN term
Radio-frequency skin contouring system applicator tip
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.4400
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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 contouring system applicator tip

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

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)