Identity
- Trade Name
- Ignite RF System FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- The Ignite RF System employs radiofrequency (RF) energy for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The System operates when the Handpiece is connected.The System provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for the specific treatment. The System provides enhanced safety while minimizing possible side effects by monitoring RF parameters and tissue temperature. FDA UDI
- Model / Reference
- AG613237A FDA UDI
- Description
- The Ignite RF System employs radiofrequency (RF) energy for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. The System operates when the Handpiece is connected.The System provides individual adjustment of treatment parameters to achieve maximum efficiency and safety for the specific treatment. The System provides enhanced safety while minimizing possible side effects by monitoring RF parameters and tissue temperature. FDA UDI
Identifiers
- Catalog Number
- AG613237A FDA UDI
- Primary DI / UDI-DI
- 07290019863250 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
Ignite RF System by Inmode MD , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K182325 also covers:
K233642 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 |
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Manufacturer
- Manufacturer
- Inmode MD , Ltd.
Sources (1)
- FDA UDI d5f45c8b-5d11-4d06-9ece-00c71758c794 37 fields · synced May 30, 2026