Identity
- Trade Name
- Morpheus8 24 pin TIP FDA UDI
- Generic Name
- Radio-frequency skin contouring system applicator tip FDA UDI
- Device Name
- Morpheus8 - 24 Pin TIP FDA UDI
- Model / Reference
- AG613054A FDA UDI
- Description
- Morpheus8 - 24 Pin TIP FDA UDI
Identifiers
- Catalog Number
- AG613054A FDA UDI
- Primary DI / UDI-DI
- 07290019863113 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Radio-frequency skin contouring system applicator tip FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency skin contouring system applicator tip
Morpheus8 24 pin TIP by Inmode MD , Ltd. — Class II — FDA UDI — listed in FDA GUDID — 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 40 pin TIP — Inmode MD , Ltd.
- Morpheus8 Burst Applicator — Inmode MD , Ltd.
- Morpheus8 Burst Deep Applicator — Inmode MD , Ltd.
- Morpheus8 Prime 12 pin TIP — Inmode MD , Ltd.
- Morpheus8 Resurfacing TIP — Inmode MD , Ltd.
- OptimasMax platform — Inmode MD , Ltd.
- Plus Applicator — Inmode MD , Ltd.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI b3b95359-3dfc-43c7-9faf-32859f07be52 37 fields · synced May 30, 2026