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510(k) Data Aggregation
K Number
K242688Device Name
Finiff System
Manufacturer
Date Cleared
2024-12-20
(105 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Skingrab Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Finiff System is intended for use in Dermatologic and General Surgery procedures that require electrocoagulation and hemostatis.
Device Description
The Finiff System is a High Frequency Electrosurgical Unit that uses electrical currents to coagulate tissue. The Finiff System consists of a console that houses an RF generator as well as the electronics. The user interface is a touchscreen that is located on the console. There are two handpieces that attach to the console:
• The VertoRF Handpiece is a microneedling handpiece that delivers energy in 2 frequencies: 1mHz and 2mHz. The VertoRF has one disposable tip configuration that consists of 25 needles and penetrates the tissue up to 4mm in depth.
• Ther VitaRF Handpiece delivers noninvasive RF energy at a frequency of 6.78 MHz. The VitaRF handpice has 2 Treatment Tips: the VitaRF F-Tip and the VitaRF E-Tip
In addition to the console and the 2 handpieces, there are accessories as follows:
• Power Cord
• Footswitch (optional)
• Cryogen canister
• Return Pad
• Coupling fluid
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