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510(k) Data Aggregation
K Number
K243716Device Name
Zionic Pro Max (Radiofrequency)
Manufacturer
TermoSalud S.L.
Date Cleared
2025-05-28
(177 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Product Code :
PBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ZIONIC PRO MAX (radiofrequency) equipment when used with the capacitive or resistive handpiece is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.
Device Description
The Zionic Pro Max with Radiofrequency is a non-invasive topical heating device that produces RF energy to warm subcutaneous tissue the therapeutic temperature of 40-45°C. The device includes two different type of RF handpieces, resistive and capacitive, which are connected to a console and software-powered user interface. The Zionic Pro Max adds a new capacitive handpiece and user interface to a previously cleared generation of the device.
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K Number
K241733Device Name
HEBE (NP0000763); HERA (NP0000706)
Manufacturer
Novasonix Technology S.L
Date Cleared
2025-04-16
(303 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Product Code :
PBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HEBE is intended to provide topical heating to elevate tissue temperature for the treatment of selected medical conditions, including pain relief, muscle spasm reduction, and increased local circulation.
Device Description
HEBE is a device indicated for radiofrequency (RF) treatments at 448kHz. This frequency is associated with pain reduction and improved functionality in patients with musculoskeletal disorders. This wavelength promotes ion mobilization between the intracellular and extracellular matrix and restores cell membrane permeability. The energy generated at 448 kHz improves cell membrane permeability, enhancing intracellular and extracellular exchange and tissue regeneration. Furthermore, high-intensity radiofrequency treatment at 448 kHz can induce significant hyperthermia, which can lead to a considerable increase in cell metabolism and accelerated recovery. These hyperthermal adaptations to radiofrequency treatment are based on vasodilatation, causing a targeted local increase of blood perfusion and decreases in muscle tension and spasm, increased oxygen and nutrient supply, and healing acceleration.
RF treatment can be applied through either capacitive or resistive electrodes that pass radiofrequency to the human body.
HEBE has 3 different technologies:
- Monopolar Capacitive Radiofrequency
- Monopolar Resistive Radiofrequency
- Bipolar Resistive Radiofrequency
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K Number
K243055Device Name
Préime DermaFacial Collagen+
Manufacturer
EMA Aesthetics, LTD
Date Cleared
2025-04-15
(200 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Product Code :
PBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Préime DermaFacial with Collagen+ Applicator is intended to relieve minor muscle aches and pain, relieve muscle spasms, temporarily improve local blood circulation, temporarily improve the appearance of cellulite.
Device Description
Not Found
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K Number
K242175Device Name
XOD Diathermia Radiofrequency Device
Manufacturer
XOD Inc.
Date Cleared
2025-02-27
(218 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Product Code :
PBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The XOD diathermia radiofrequency device is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The XOD device also is intended to provide a temporary reduction in the appearance of cellulite.
Device Description
The XOD diathermia radiofrequency device generates high frequency sinusoidal current with a monopolar mode of application using two electrodes. A fixed electrode is placed in contact with the patient and a handheld electrode is manipulated by a therapist. When both electrodes are in contact with a patient the electrical circuit is closed, and RF therapy can be provided. The device can be operated in a resistive monopolar mode.
The product consists of a portable power console with a color touchscreen, and accessories including resistive threaded electrodes, and a silicon return plate. The unit can be adjusted to provide various levels of treatment frequency ranging from 442kHz to 454MHz.
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K Number
K241107Device Name
Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)
Manufacturer
INDIBA S.A.U
Date Cleared
2025-01-24
(277 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Product Code :
PBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indiba Diathermia Radiofrequency Deep Care/Activ devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.
The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
Device Description
The INDIBA Diathermia Radiofrequency Activ device model (Activ CT9 device) and the INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device), are noninvasive, diathermy, therapeutic devices, which employ RF current.
The device models consist of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes, stainless steel conductive resistive electrodes (RES), and thin layer insulated capacitive electrodes (CAP). The electrodes are inserted into a handle, and the handle is connected to the console by a designated cable, the generated current flows through the patient and returns to the device through the neutral return electrode.
The Activ CT9 device model is equipped with additional massage applicators which provide mechanical massage for the temporary reduction in the appearance of cellulite.
The INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model comprise a user interface (touchscreen) to facilitate the user device operation and to enable the user to predefine the device treatment settings.
The INDIBA Diathermia Radiofrequency Deep Care device model device incorporates smart handles and smart electrodes, which enables the device to automatically identify the connected applicators and enables their operation via the control options on the touchscreen.
The EVONY device provides a new temperature tracking tool enabling the user to track the patient skin temperature during the treatment time.
Improvements were performed in both device models in the console design and in the graphical user interface (GUI).
New applicators were introduced for the INDIBA Diathermia Radiofrequency Activ device model - the Fascia and Target electrodes and for the INDIBA Diathermia Radiofrequency Deep Care device model - the Sculpture electrodes. The new electrodes behave and operate in the same manner as the already FDA cleared RES and CAP electrodes.
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K Number
K232966Device Name
FISIOWARM 7.0
Manufacturer
Golden Star Srl
Date Cleared
2024-12-26
(462 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Product Code :
PBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation. The massage devices are intended to provide a temporary reduction in the appearance of cellulite.
Device Description
FISIOWARM® 7.0 300 and FISIOWARM® 7.0 400 are active and therapeutic medical devices that perform their function by releasing energy to the human body.
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K Number
K242553Device Name
MIRARI® Cold Plasma System ( GV-M2-01)
Manufacturer
General Vibronics, Inc.
Date Cleared
2024-11-21
(86 days)
Product Code
PBX, GEI
Regulation Number
878.4400Why did this record match?
Product Code :
PBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
MIRARI® Cold Plasma System provides heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms and increase in local circulation.
Device Description
The Mirari Cold Plasma System is a portable, hand-held device that emits RF energy at 80kHz. The system is comprised of a battery-operated RF generator, a rechargeable power supply powered by a pair of lithium batteries and a plasma array which is placed in fleece pouch. The plasma array is then placed in a fleece pouch which is then placed on the RF energy is emitted through the array..
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K Number
K243164Device Name
INDIBA COMPACT devices
Manufacturer
INDIBA S. A. U.
Date Cleared
2024-11-20
(51 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Product Code :
PBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INDIBA COMPACT devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain. muscle spasms and increase in local circulation.
The massage electrodes are intended to provide a temporary reduction in the appearance of cellulite.
Device Description
The INDIBA COMPACT devices are therapeutic devices for deep, non-invasive diathermy. The device consists of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes: steel conductive resistive electrodes, and thin-layer insulated capacitive electrodes are inserted into a handle/handpiece, one handle for each kind of electrode, and the handle is connected to the console by means of a cable.
In resistive mode the system delivers a high- frequency current of 448 kHz directly to the patient's skin surface. In capacitive mode, the electrode coating creates a layer between the electrode and the human tissue, forming a capacitor that allows a high-frequency current at 448 kHz to pass. Current returns through the neutral return electrode.
INDIBA Compact devices are provided with an electroconductive media which is applied to the patients' skin prior to each treatment session. The RF energy generates a heating profile that produces a moderate temperature rise in the subcutaneous tissue. In Compact Lite, the temperature on the skin is measured using a separate IR (Infra-red) thermometer and in Compact Plus and Compact Pro temperature is measured through the smart electrodes and smart handle, which inform of the surface skin temperature trough a color scale. There are also other accessories available as massage electrodes with different shapes that can be used to massage the skin during cellulite treatment.
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K Number
K242598Device Name
DEFINE System (AG612444A)
Manufacturer
InMode Ltd.
Date Cleared
2024-11-14
(76 days)
Product Code
PBX, GEI, ISA, NUV
Regulation Number
878.4400Why did this record match?
Product Code :
PBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The DEFINE System with the non-invasive applicators employs RF energy for various applications:
The DEFINE System with the Cheek and Chin Applicators is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.
The DEFINE System with the FORMA Applicator is intended for the relief of minor muscle aches and pain. relief of muscle spasm. and for the temporary improvement of local blood circulation.
The DEFINE System with the MiniFX Applicator is intended for the relief of minor muscle aches and pain, relief of muscle spasm, for the temporary improvement of local blood circulation and for the temporary reduction in the appearance of cellulite.
The DEFINE System with the Morpheus8 Applicator is intended for use in dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed.
At higher energy levels greater than 62 mJ/pin, the use of the Morpheus8 Applicator is limited to Skin Types I-IV.
Device Description
The DEFINE device is designed to deliver non-thermal RF energy to the skin and subdermal fat. The RF energy is transmitted to the Applicators and delivered to the treatment area throughout the set of RF electrodes positioned on the treatment units. The invested RF energy is transformed into local heating of the treatment area. Local heating of the skin and underlying tissue layers temporarily ease the symptoms of muscle aches, pain & spasm. It also contributes to the temporary improvement of local blood circulation.
The DEFINE device platform comprises a AC/DC power supply unit, main controller, two RF generators, distributor card and user interface including a touch screen. The system platform contains four designated connectors for the following applicators:
- Cheek Applicator (hands-free) ●
- Chin Applicator (hands-free) ●
- FORMA Applicator ●
- MiniFX ●
- MORPHEUS8 Applicator with the resurfacing, 12 and 24 pin tip heads ●
The DEFINE device RF Applicators are connected to the console via a cable. The delivery of the RF Energy is controlled by a "Start"/"Stop" button on the LCD screen or by a foot pedal. The DEFINE device incorporates a treatment deactivation button. Pressing the deactivation button by either the patient or caregiver would immediately halt the treatment and switch the device into a Pause mode until the operator re-enables it.
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K Number
K240991Device Name
eMVFit (MVF-10M)
Manufacturer
Weero Co., Ltd.
Date Cleared
2024-10-09
(181 days)
Product Code
PBX, GEI
Regulation Number
878.4400Why did this record match?
Product Code :
PBX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The eMVFit (MVF-10M) Radio frequency is used for:
· Relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.
· Temporary reduction in the appearance of cellulite.
Device Description
eMVFit has MULTI handpiece, EMS handpiece, patient switch, cradle, distilled water injection hose & funnel, key switch and power cable.
eMVFit has a user interface including an LCD touch screen and has MULTI mode and EMS mode.
MULTI mode has RF and EMS functions that use the MULTI handpiece.
In the case of RF, the target temperature can be set and a vacuum can be used together, and a cooling function can be used as a safety system to prevent burns on the skin surface.
In addition, the MULTI handpiece has a temperature sensor, so the output is automatically turned off when the skin surface temperature exceeds 43°C.
EMS mode has an EMS function that uses the EMS handpiece.
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