Identity
- Trade Name
- FRACTORA 3D-90 Tip FDA UDI
- Generic Name
- Radio-frequency skin contouring system applicator tip FDA UDI
- Device Name
- Morpheus8V Tip (24 pin) - 4 units in pack FDA UDI
- Model / Reference
- AG607403A FDA UDI
- Description
- Morpheus8V Tip (24 pin) - 4 units in pack FDA UDI
Identifiers
- Catalog Number
- AG607403A FDA UDI
- Primary DI / UDI-DI
- 07290016633719 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Radio-frequency skin contouring system applicator tip
FRACTORA 3D-90 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
K180189 also covers:
K201150 also covers:
K210492 also covers:
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- 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.
- FormaI — Inmode MD , Ltd.
- Luxora System — Inmode MD , Ltd.
- Morpheus8 TIP — 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.
- 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.
- Lumecca Peak — 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 af2d6d57-e411-4bf0-ba74-586f4d9d82b8 37 fields · synced May 30, 2026