Identity
- Trade Name
- InMode FDA UDI
- Generic Name
- Multi-modality skin surface treatment system FDA UDI
- Device Name
- InMode System 2 - color 2 - Triton The InMode Diolaze XL System with the Diolaze XL 810nm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal. The InMode VLaze is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains,leg veins and other benign vascular lesions. FDA UDI
- Model / Reference
- AG606992A FDA UDI
- Description
- InMode System 2 - color 2 - Triton The InMode Diolaze XL System with the Diolaze XL 810nm Hand piece is intended for hair removal and permanent hair reduction defined as the stable, long-term reduction in hair counts at 6, 9, or 12 months following a treatment regime.The InMode Diolaze XL System with the Diolaze XL 755/810nm & 810/1064nm Hand pieces is intended for hair removal. The InMode VLaze is intended for the treatment of vascular lesions, including angiomas, hemangiomas, telangiectasia, port wine stains,leg veins and other benign vascular lesions. FDA UDI
Identifiers
- Catalog Number
- AG606992A FDA UDI
- Primary DI / UDI-DI
- 07290016633382 FDA UDI
- FDA Product Code
- GEX FDA UDI
- GMDN Term
- Multi-modality skin surface treatment system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4810 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
InMode 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
K170738 also covers:
K173677 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 2aa84bfe-eb82-42b7-9b38-06f8b2607e77 37 fields · synced May 30, 2026