Identity
- Trade Name
- CelluTite System FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- The CelluTite System with the BodyFX and Plus Handpieces is a medical aesthetic device combining mechanical vacuum skin massaging and non-thermal RF energy for the treatment of selected medical conditions such as relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. Morpheus8C employs bi-polar Radio-frequency (RF) technology for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis for various aesthetic applications. The device provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for each patient and applications. FDA UDI
- Model / Reference
- AG612700A FDA UDI
- Description
- The CelluTite System with the BodyFX and Plus Handpieces is a medical aesthetic device combining mechanical vacuum skin massaging and non-thermal RF energy for the treatment of selected medical conditions such as relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite. Morpheus8C employs bi-polar Radio-frequency (RF) technology for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis for various aesthetic applications. The device provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for each patient and applications. FDA UDI
Identifiers
- Catalog Number
- AG612700A FDA UDI
- Primary DI / UDI-DI
- 07290019863014 FDA UDI
- 510(k) Number
- K210492 FDA UDI
- FDA Product Code
- GEI FDA UDIPBX FDA UDIISA FDA UDINUV FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4400 FDA UDI890.5660 FDA UDI878.4810 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
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
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Multi-modality skin surface treatment system
CelluTite System by Inmode MD , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Multi-modality skin surface treatment system.
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- Handpiece 570 (6.4) for Harmony XL — ALMA LASERS LTD. · Class II
- Tip ClearLift QS KTP 532 4mm (Female) — ALMA LASERS LTD. · Class II
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- OXYLIGHT — RAJA Medical · Class II
- 2940 handpiece — Cynosure, LLC · Class II
Cleared under the same submission
K210492 also covers:
- APEX RF System — Inmode MD , Ltd.
- ApexRF Applicator — 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.
- Morpheus8 TIP — Inmode MD , Ltd.
- Morpheus8C Handpiece — 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 |
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Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (1)
- FDA UDI ac7ce256-5a31-403d-8ccd-f06dfe9eaf87 37 fields · synced May 30, 2026