Identity
- Trade Name
- Morpheus8 TIP FDA UDI
- Generic Name
- Radio-frequency skin contouring system applicator tip FDA UDI
- Device Name
- Morpheus8 24pin Tip EUDAMEDMorpheus8 - 24 Pin TIP FDA UDI
- Model / Reference
- AG607563A EUDAMEDFDA UDI
- Description
- Morpheus8 - 24 Pin TIP FDA UDI
Identifiers
- Catalog Number
- AG607563A FDA UDI
- Primary DI / UDI-DI
- 07290016633443 EUDAMEDFDA UDI
- Basic UDI-DI
- B-07290016633443 EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12040218 ENDERMOLOGY TREATMENTS EUDAMED
- GMDN Term
- Radio-frequency skin contouring system applicator tip FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Radio-frequency skin contouring system applicator tip
Morpheus8 TIP by Inmode MD , Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Radio-frequency skin contouring system applicator tip.
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Cleared under the same submission
K192695 also covers:
K200947 also covers:
K201150 also covers:
K210492 also covers:
- APEX RF System — Inmode MD , Ltd.
- ApexRF Applicator — Inmode MD , Ltd.
- CelluTite System — Inmode MD , Ltd.
- EMPOWER ENVISION — Inmode MD , Ltd.
- EmPowerRF platform — Inmode MD , Ltd.
- Envision System — Inmode MD , Ltd.
- FRACTORA 3D-90 Tip — Inmode MD , Ltd.
- FormaI — Inmode MD , Ltd.
- Luxora System — Inmode MD , Ltd.
- Morpheus8C Handpiece — Inmode MD , Ltd.
K221571 also covers:
- Diolaze XL 755/810 Applicator — Inmode MD , Ltd.
- Diolaze XL 810 Applicator — Inmode MD , Ltd.
- Diolaze XL 810/1064 Applicator — Inmode MD , Ltd.
- Diolaze XL Max Applicator — Inmode MD , Ltd.
- Envision System — Inmode MD , Ltd.
- FRACTORA 3D-90 Tip — Inmode MD , Ltd.
- FormaV Applicator — Inmode MD , Ltd.
- Fusion Dark Applicator — Inmode MD , Ltd.
- Fusion Light Applicator — Inmode MD , Ltd.
- InMode OP — Inmode MD , Ltd.
- Lumecca I — Inmode MD , Ltd.
- Lumecca Peak — Inmode MD , Ltd.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (2)
- FDA UDI 458aa5fc-7da2-45a3-ac3e-77fb7713752d 37 fields · synced Jun 18, 2026
- EUDAMED 122db8de-07a4-4858-964f-3c537fe728eb 61 fields · synced Jun 18, 2026