Identity
- Trade Name
- Morpheus8 Prime 12 pin TIP FDA UDIMorpheus8 FDA UDI
- Generic Name
- Radio-frequency skin contouring system applicator tip FDA UDI
- Device Name
- Morpheus8 12 pin Tip EUDAMEDMorpheus8 Prime 12pin Tip FDA UDIMorpheus8 Prime 12p Tip FDA UDI
- Model / Reference
- AG609136A EUDAMEDFDA UDIAG613052A FDA UDI
- Description
- Morpheus8 Prime 12pin Tip FDA UDIMorpheus8 Prime 12p Tip FDA UDI
Identifiers
- Catalog Number
- AG613052A FDA UDIAG609136A FDA UDI
- Primary DI / UDI-DI
- 07290016633634 EUDAMEDFDA UDI07290019863090 FDA UDI
- Basic UDI-DI
- B-07290016633634 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
- Romania 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 Prime 12 pin TIP by Inmode MD , Ltd. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Radio-frequency skin contouring system applicator tip.
- triFX — POLLOGEN LTD · Class II
- triFX — POLLOGEN LTD · Class II
- INTRAgen Tip — Jeisys Medical Inc. · Class II
- VOLNEWMER F tip(D) — CLASSYS Inc. · Class II
- VOLNEWMER S tip — CLASSYS Inc. · Class II
- triFX — POLLOGEN LTD · Class II
- VOLNEWMER V tip(D) — CLASSYS Inc. · Class II
- Thermage — Solta Medical, Inc. · Class I
Cleared under the same submission
K231790 also covers:
K251632 also covers:
- Diolaze XL Max Applicator — Inmode MD , Ltd.
- Fusion Dark Applicator — Inmode MD , Ltd.
- Fusion Light Applicator — Inmode MD , Ltd.
- Lumecca Peak — Inmode MD , Ltd.
- Lumecca Peak — Inmode MD , Ltd.
- Morpheus8 24 pin TIP — Inmode MD , Ltd.
- Morpheus8 40 pin TIP — Inmode MD , Ltd.
- Morpheus8 Burst Applicator — Inmode MD , Ltd.
- Morpheus8 Burst Deep Applicator — Inmode MD , Ltd.
- Morpheus8 Resurfacing TIP — Inmode MD , Ltd.
- OptimasMax platform — Inmode MD , Ltd.
- Plus Applicator — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (3)
- FDA UDI b6795a57-6553-435e-9696-afad6a17455c 37 fields · synced Jun 20, 2026
- FDA UDI c118fef3-1260-4811-a65c-e140c1202122 37 fields · synced May 30, 2026
- EUDAMED 65739bd7-a002-403e-a7dc-e45f73af13f6 61 fields · synced Jun 20, 2026