Search Results
Found 7 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?
Search-Everything :
Matched: '878.5350'
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.
Ask a Question
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?
Search-Everything :
Matched: '878.5350'
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).
Ask a Question
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?
Search-Everything :
Matched: '878.5350'
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).
Ask a Question
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?
Search-Everything :
Matched: '878.5350'
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).
Ask a Question
K Number
K182355Device Name
Secret RF Smartcure Applicator with electrodes
Manufacturer
Ilooda Co., Ltd.
Date Cleared
2019-09-06
(372 days)
Product Code
GEI, KCW, ONQ, OUH
Regulation Number
878.4400Why did this record match?
Search-Everything :
Matched: '878.5350'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Secret RF Smartcure applicator is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
Device Description
Secret RF's High Frequency(=Radio Frequency) includes the system main body, a handpices with singleuse micro-needle type electrodes, footswitch and an LCD touch screen control panel.
The HF energy is delivered to the target tissue using a handpiece and disposable tip(micro needle electrode tip), the tip being placed in light contact with the epidermis and the handpiece being held at right angles to the target tissue. As the HF energy passes through the skin, it generates an electro thermal reaction, which is capable of coagulating the tissue. Using the micro needle tip, the Secret RF system creates heat within the target dermal tissue via micro-needles inserted from the tip.
The Secret RF is consists of ;
- 1) Secret RF main unit (FDA cleared K170325)
- 2) Bipolar type handpieces with Bipolar type micro-needle electrodes (FDA cleared K170325)
- 3) Secret RF Smartcure applicator
The Secret RF Smartcure Applicator consists of :
- Smartcure handpiece
- Monopolar type micro-needle electrodes (MTR-AC-01 , MTR-AC-04, MTR-AC-27G, K3i)
Ask a Question
K Number
K160469Device Name
AGNES
Manufacturer
GOWOONSESANG COSMETICS CO., LTD
Date Cleared
2017-01-05
(321 days)
Product Code
GEI, KCW, THE
Regulation Number
878.4400Why did this record match?
Search-Everything :
Matched: '878.5350'
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 hand-piece, Single use RF electrodes (needle type). Disposable neutral electrode pad and a footswitch.
Ask a Question
K Number
K021149Device Name
AURORA DS
Manufacturer
SYNERON MEDICAL LTD.
Date Cleared
2002-07-09
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Search-Everything :
Matched: '878.5350'
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Aurora DS is intended for use in dermatology for non invasive hair removal.
The Aurora DS is indicated for non-invasive hair removal.
Device Description
The Aurora DS is a device that is used for non-invasive hair removal. The Aurora DS treatment is based on a principle of selective thermolysis. According to this principle, parameters of optical and RF energy (spectrum, exposure duration and energy density) are chosen (and optimized) to selectively damage (destroy) hair and follicle without damaging the surrounding tissues.
Ask a Question
Page 1 of 1