LUDWIG Electrosurgical Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221574 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The LUDWIG Electrosurgical Device is a general electrosurgical device used in plastic surgery procedures. It delivers electrical energy to tissue for cutting, coagulation, or ablation during surgical interventions.
The device is supplied by Aesthetics Biomedical and is authorized under FDA 510K clearance with product code GEI. It is not specified as single-use or reusable, and no MRI safety information is provided. The device is stored at the manufacturer's facility in Phoenix, Arizona.
Frequently asked questions
What is the LUDWIG Electrosurgical Device used for?
The LUDWIG Electrosurgical Device is a general electrosurgical device used in plastic surgery procedures to deliver electrical energy to tissue for cutting, coagulation, or ablation during surgical interventions.
How is the LUDWIG Electrosurgical Device supplied?
The device is supplied by Aesthetics Biomedical, with its manufacturing facility located at 4602 N. 16th St., Suite 300, Phoenix, Arizona 85016.
Is the LUDWIG Electrosurgical Device single-use or reusable?
The device description does not specify whether it is designed for single-use or reusable applications, indicating this information may be available in additional product documentation.
What is the regulatory status of the LUDWIG Electrosurgical Device?
The LUDWIG Electrosurgical Device is authorized under FDA 510K clearance with product code GEI, having received a decision of 'Substantially Equivalent' on October 16, 2022.
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 | K221574 | Class II | Active |
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Manufacturer
- Manufacturer
- Aesthetics Biomedical
Sources (1)
- FDA 510(k) K221574 24 fields · synced Sep 23, 2026