ELUMI 810 + 980 Soft Tissue Laser
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152032 FDA 510(k)
- FDA Product Code
- GEX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ELUMI 810 + 980 Soft Tissue Laser is a medical device designed for soft tissue procedures. It utilizes dual wavelengths of 810nm and 980nm for various surgical applications in soft tissue treatment.
This device is supplied by Azena Medical, LLC and is intended for single-use or reusable applications as specified by the manufacturer. It is MRI conditional and has received FDA 510(k) clearance with product code GEX. The device is stored according to the manufacturer's instructions and is authorized for use in general and plastic surgery settings.
Frequently asked questions
What is the ELUMI 810 + 980 Soft Tissue Laser used for?
The ELUMI 810 + 980 Soft Tissue Laser is designed for various soft tissue procedures in general and plastic surgery settings. It utilizes dual wavelengths of 810nm and 980nm for different surgical applications in soft tissue treatment.
Is the ELUMI 810 + 980 Soft Tissue Laser single-use or reusable?
The ELUMI 810 + 980 Soft Tissue Laser can be used as either single-use or reusable, depending on the specifications provided by the manufacturer, Azena Medical, LLC.
What regulatory approvals does the ELUMI 810 + 980 Soft Tissue Laser have?
The ELUMI 810 + 980 Soft Tissue Laser has received FDA 510(k) clearance with product code GEX. It is MRI conditional and is authorized for use in general and plastic surgery settings.
How should the ELUMI 810 + 980 Soft Tissue Laser be stored?
The ELUMI 810 + 980 Soft Tissue Laser should be stored according to the manufacturer's instructions. Specific storage requirements are detailed in the product documentation provided by Azena Medical, LLC.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152032 | Class II | Active |
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Manufacturer
- Manufacturer
- Azena Medical, LLC
Sources (1)
- FDA 510(k) K152032 24 fields · synced Sep 21, 2026