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510(k) Data Aggregation
K Number
K242996Device Name
EndyMed PRO MAX
Manufacturer
EndyMed Medical Ltd.
Date Cleared
2025-06-10
(257 days)
Product Code
GEI, OUH, PBX
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
EndyMed Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PRO MAX system is a Radiofrequency device intended for use in dermatologic procedures with separate indications for each handpiece.
The TC Handpieces (Shaper Max, Mini Shaper Max, iFine Max) are intended for:
• Relief of minor muscle aches and pain, relief of muscle spasm
• Temporary improvement of local blood circulation
When used up to 65W, the Mini Shaper Max and Small Max handpieces are also intended for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
The FSR Max Handpiece is intended for dermatological procedures requiring ablation and resurfacing of the skin.
The Intensif MAX Handpiece is intended for use in dermatologic procedures for electrocoagulation and hemostasis.
The EndyMed Contour MAX Handpiece is intended for the treatment of the following medical conditions; using the Contour MAX applicator for delivery of non-thermal RF combined with massage:
• 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
ENDYMED PRO™ MAX is a computerized system that generates pulses of radio frequency (RF) energy that are emitted onto patient skin. The device consists of a console and seven handpieces that emit either ablative or non-ablative radiofrequency.
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K Number
K161715Device Name
EndyGel
Manufacturer
EndyMed Medical Ltd.
Date Cleared
2017-02-07
(231 days)
Product Code
GYB
Regulation Number
882.1275Why did this record match?
Applicant Name (Manufacturer) :
EndyMed Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Endy Gel is an Electroconductive gel media used with external electrode to reduce the impedance to alternating current) of the contact between the electrode surface and the skin.
Device Description
EndyMed's EndyGel™ is an Electroconductive gel media used with external electrode to enhance electrical conductivity by reducing the impedance (resistance to alternating current) of the radiofrequency signals path from the electrode surface between the electrode surface and the skin.
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K Number
K161199Device Name
EndyMed Contour Handpiece
Manufacturer
ENDYMED MEDICAL LTD.
Date Cleared
2016-08-01
(95 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ENDYMED MEDICAL LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndyMed Contour Handpiece is intended for the treatment of the following medical conditions; using the Contour applicator for delivery of non-thermal RF combined with massage:
- · 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
EndyMed's EndyMed Contour Handpiece is a treatment handpiece to be attached to the FDA cleared EndyMed Imagine TC Skin Treatment System (Imagine K08346). The EndyMed Contour Handpiece combines suction module that creates vacuum energy and emits bipolar RF energy that flows between the electrodes to create thermal heating of the tissue.
The Vacuum is used for the massaging of deep tissues by creating mild to deep suction. The vacuum massage contributes to the sub-dermal and adipose tissues shrinkage and improves the contact surface between electrodes and tissue.
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K Number
DEN150005Device Name
Newa Skin Therapy System
Manufacturer
EndyMed Medical Ltd.
Date Cleared
2015-12-18
(336 days)
Product Code
PAY
Regulation Number
878.4420Why did this record match?
Applicant Name (Manufacturer) :
EndyMed Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndyMed Newa™ is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
Device Description
The Newa™ is an OTC, home use hand held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of:
- User interface
- Programmable logic controller (PLC)
- RF power module
- Power supply
- RF electrodes
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