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Found 5 results
510(k) Data Aggregation
K Number
K242469Device Name
RFMagik Lite
Manufacturer
Agnes Medical Co., Ltd
Date Cleared
2025-04-25
(248 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Agnes Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
RFMagik Lite is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch. There are two handpieces. RO handpiece and AGNES RF handpiece that delivers RF energy through the disposable electrode in the handpiece.
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K Number
K230837Device Name
PlazMagik
Manufacturer
Agnes Medical Co., Ltd
Date Cleared
2024-02-29
(339 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Agnes Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PlazMagik is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
The AGNES MEDICAL CO.,LTD PlazMagik is an electro-surgical device for use in dermatological applications. The effect of the device is achieved by heating the outer layer of the skin to that part or all or the epidermis becomes non-viable and there is controlled damage to the underlying dermis.
The PlazMagik system consists of a system console, footswitch, Two type of handpiece and tip guide.
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K Number
K223805Device Name
Agnes
Manufacturer
Agnes Medical Co., Ltd
Date Cleared
2023-05-04
(136 days)
Product Code
GEI, KCW
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Agnes Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Device Description
AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a footswitch, a hand-piece, single use RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).
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K Number
K203013Device Name
AGNES
Manufacturer
Agnes Medical CO., LTD
Date Cleared
2022-07-14
(651 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Agnes Medical CO., LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Device Description
AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a footswitch, a hand-piece, single use needle type RF electrodes and FDA cleared Disposable neutral electrode pad (K102372).
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K Number
K192728Device Name
Agnes
Manufacturer
Agnes Medical Co., Ltd
Date Cleared
2019-10-24
(27 days)
Product Code
GEI, KCW
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Agnes Medical Co., Ltd
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Device Description
AGNES is a RF electrosurgical device. It consists of LCD screen, radiofrequency generator and SMPS. The accessories are a footswitch, a hand-piece, FDA cleared Single use needle type RF electrodes (K171707) and FDA cleared Disposable neutral electrode pad (K102372).
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