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510(k) Data Aggregation
K Number
K130793Device Name
NEWA SKIN THERAPY SYSTEM
Manufacturer
ENDYMION MEDICAL LTD
Date Cleared
2013-08-16
(147 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ENDYMION MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The EndyMed Newa is a prescription home use device intended for non-invasive treatment of mild to moderate facial wrinkles and rhytides
Device Description
The Newa™ is a noninvasive, non-ablative, prescription home use hand held device consisting of:
- User interface .
- Programmable Logic controller (PLC) ●
- RF power module ●
- Power Supply .
- RF Electrodes ●
The interface allows the selection of heating level by using the Power Level Switch as follows:
- "0" mode = the device is "OFF". .
- . "1" mode = low heating level.
- . "2" mode = high heating level.
The PLC is a specially configured computer that provides the operational and safety function of the system.
The RF power module provides RF energy to the active tip, producing a sinusoidal signal at a 1MHz frequency.
Based on 3DEEP® technology, the Newa™ is comprised of 3 pairs of bipolar RF electrodes. The RF is emitted into the skin creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis, dermis or hypodermis.
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K Number
K083461Device Name
IMAGINE TC SKIN THERAPY SYSTEM
Manufacturer
ENDYMION MEDICAL LTD
Date Cleared
2009-07-24
(245 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ENDYMION MEDICAL LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Imagine TC Skin Treatment System is a noninvasive device intended for use in Dermatologic and General Surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides
Device Description
The Imagine Skin Treatment System is a noninvasive, non-ablative device consisting of: User interface Programmable Logic controller (PLC) RF power module Thermoelectric cooling (TEC) module Two treatment handpieces (small and large) The interface allows the selection of treatment parameters by pressing on the treatment buttons; LCD screen displays the current treatment settings. The PLC is a specially configured computer that provides the operational and safety function of the system. Handpieces incorporating: Treatment handpieces with thermoelectric cooling (TEC) that maintains electrodes at ambient temperature. The RF power module provides RF energy to the handpiece, producing a sinusoidal signal at a 1000 kHz frequency
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