Search Results
Found 4 results
510(k) Data Aggregation
K Number
K213612Device Name
SYLFIRM X
Manufacturer
VIOL Co., Ltd.
Date Cleared
2022-06-23
(220 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
VIOL Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SYLFIRM X™ is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
Device Description
The SYLFIRM X™ includes a system main device, a hand-piece equitable with a bi-polar electrode, and a foot switch. The RF signal is generated from the main device which is then delivered to the handpiece and then to bi-polar electrode. The RF signal is delivered to the target tissue using penetrating needle electrodes in the consumable tip. The bi-polar electrode is placed in light contact with the epidermis while the hand-piece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SYLFIRM X™ creates heat within the target skin tissue via needle electrodes from the bi-polar electrode.
Ask a Question
K Number
K200185Device Name
SYLFIRM X
Manufacturer
Viol Co., Ltd.
Date Cleared
2020-04-22
(89 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Viol Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SYLFIRM X™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
The SYLFIRM X™ includes a system main device, a probe equitable with a consumable tip, and a foot switch. The RF signal is generated from the main device which is then delivered to the probe and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the consumable tip. The consumable tip is placed in light contact with the epidermis while the probe is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SYLFIRM X™ creates heat within the target skin tissue via needle electrodes from the consumable tip.
Ask a Question
K Number
K180872Device Name
SCARLET SRF
Manufacturer
Viol Co., Ltd.
Date Cleared
2018-10-11
(191 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Viol Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The SCARLET SRF is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
The SCARLET SRF includes a system main device, a hand-piece equipped with a tip, and a footswitch. The RF signal is generated from the main device which is then delivered to the handpiece and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the tip. The tip is placed in light contact with the epidermis while the handpiece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, SCARLET SRF creates heat within the target skin tissue via needle electrodes from the consumable tip.
Ask a Question
K Number
K172023Device Name
CELFIRM
Manufacturer
VIOL Co., Ltd.
Date Cleared
2017-10-13
(100 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
VIOL Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CELFIRM™ is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
The CELFIRM™ includes a system main device, a hand-piece equipped with a tip, and a footswitch. The RF signal is generated from the main device which is then delivered to the hand-piece and then to consumable tip. The RF signal is delivered to the target tissue using penetrating needle electrodes in the tip. The tip is placed in light contact with the epidermis while the hand-piece is being held at right angles to the target tissue. As the RF signal passes through the skin, it generates an electro thermal reaction which is capable of coagulating the tissue. Using the consumable tip, CELFIRM™ creates heat within the target skin tissue via needle electrodes from the consumable tip.
Ask a Question
Page 1 of 1