Identity
- Trade Name
- Luxora System FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- The Luxora™ device is based on the InMode RF Pro™ platform. The Luxora system employs radiofrequency (RF) energy for use in dermatological procedures. The System operates when the Handpiece is connected. FDA UDI
- Model / Reference
- AG613237A FDA UDI
- Description
- The Luxora™ device is based on the InMode RF Pro™ platform. The Luxora system employs radiofrequency (RF) energy for use in dermatological procedures. The System operates when the Handpiece is connected. FDA UDI
Identifiers
- Catalog Number
- AG613238A FDA UDI
- Primary DI / UDI-DI
- 07290019863267 FDA UDI
- FDA Product Code
- GEI FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system 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
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
Luxora 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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Cleared under the same submission
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.
- Morpheus8 TIP — Inmode MD , Ltd.
- Morpheus8C Handpiece — Inmode MD , Ltd.
K231790 also covers:
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 0d3a3ff6-3427-4b45-acd0-d3390c2ee32f 37 fields · synced May 30, 2026