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510(k) Data Aggregation
K Number
K221574Device Name
LUDWIG Electrosurgical Device
Manufacturer
Date Cleared
2022-10-16
(137 days)
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Aesthetics Biomedical
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The LUDWIG Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
The LUDWIG Electrosurgical System is comprised of the following components:
- . The system's main body, which consists of:
- Touch-screen control/display panel O
- High radio frequency (RF)-generating output component at 0.5, 1 or 2 MHz o
- RF Handpiece for transfer of energy to human tissue O
- Ultrasound Handpiece for visualization of dermis and epidermis O
- Disposable bipolar micro-needle cartridge (electrode) that is inserted into RF o Handpiece and used for coagulation of human tissue
- O Power cord
The LUDWIG Electrosurgical System generates radiofrequency (RF) energy by means of high RF at .5 MHz, 1MHz. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue.
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