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510(k) Data Aggregation
K Number
K240512Device Name
Tixel i (TXLI0001)
Manufacturer
Novoxel Ltd.
Date Cleared
2024-11-04
(256 days)
Product Code
ORZ
Regulation Number
886.5200Why did this record match?
Applicant Name (Manufacturer) :
Novoxel Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tixel i is indicated for the application of localized heat and pressure therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD).
Device Description
The Tixel i is intended to deliver heat and pressure to the eyelids of patients with evaporative dry eye disease (DED) due to meibomian gland dysfunction (MGD). The Tixel i is comprised of a Console, which is connected via an umbilical tube to an applicator, referred to as "Handpiece."
The Handpiece includes a therapeutic element, the "Tip," fixated on its distal end. A clear polycarbonate illuminated Distance Gauge, mounted on the distal end of the Handpiece, covers the Tip and allows proper and safe positioning of the Handpiece on the skin prior to performing a treatment pulse. The Distance Gauge is removed only when the Tip is being cleaned.
The Tip is comprised of a gold-plated copper base and a thin-walled titanium alloy cover. The active surface of the Tip consists of an array of 24 (6×4) square-based pyramids, evenly spaced. The pyramids have a blunt apex to allow effective heat transfer and prevent any risk of mechanical puncturing of the skin. The backplane of the Tip attaches to a ceramic heater that maintains a constant temperature during operation.
During a Tixel i procedure, an Aestek plastic ocular shield (Oculo-Plastik, Inc.) is to be inserted under the eyelids on the ocular surface to protect the eye during the procedure.
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K Number
K223033Device Name
Tixel® 2 System
Manufacturer
Novoxel Ltd.
Date Cleared
2023-06-21
(265 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Novoxel Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tixel® 2 System is intended for dermatological procedures requiring ablation and resurfacing of the skin, and for treatment of periorbital wrinkles.
Device Description
The Tixel® 2 System is a thermo-mechanical fractional skin treatment device that is designed to perform ablative fractional skin treatment is achieved by transfer of energy in the form of heat to the skin to create coagulation sites. The treatment is applied through an operating Tip that consists of 81 (standard Tip) or 24 (small Tip) biocompatible titanium, square pyramidal shapes assembled over a gold-plated copper base that are heated by an underlying flat ceramic heating element. The desired skin treatment is achieved by defining the speed and distance at which the Tip contacts and pushes the skin, and the number of pulses performed. Based on the treatment parameters selected, the pyramids contact the skin surface in 81 (or 24 for the small Tip) discrete, non-overlapping areas and by the transfer of heat, a matrix of coagulation sites and thermal necrosis is generated.
Tixel 2 transfers heat to the tissue by direct conduction to target tissue in a localized manner via the discrete non-overlapping pyramids. The complete Tixel 2 System contains two Handpieces, which are attached to the Tixel 2 Console by an umbilical tube. The Console's touch screen is used to control the system parameters.
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K Number
K202988Device Name
Tixel System
Manufacturer
Novoxel Ltd.
Date Cleared
2021-02-25
(148 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Novoxel Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Tixel® System is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Device Description
The Tixel is a thermo-mechanical fractional skin treatment device that is designed to perform ablative fractional skin treatment is achieved by transfer of energy in the form of heat to the skin to create coagulation sites.
The treatment is applied through an operating Tip that consists of 81 (standard tip) or 24 (small tip) biocompatible titanium square pyramidal shape assembled over gold plated copper base that are heated by an underlying flat ceramic heating element. The desired skin treatment is achieved by defining the speed and distance at which the Tip contacts and pushes the skin and the amount of pulses performed. Based on the treatment parameters selected the pyramids contact the skin surface in 81 (or 24 for small tip) discrete, non-overlapping areas and by the transfer of heat, a matrix of coagulation sites and thermal necrosis is generated.
Tixel transfers heat to the tissue by direct conduction to target tissue in a localized manner via the discrete non-overlapping pyramids. The Tixel Tip contacts the skin for a very short period. defined by pulse duration that varies between 5 and 16ms.
The Tip is mounted directly above the heating element in the Handpiece. The Tip and the heating element are mounted on a titanium alloy assembly. The Tip assembly structure is rigidly connected to the motor shaft (also known as forcer) by a polymer component. The polymeric components provide both thermal and electrical insulation between the heating element and the motor shaft. The Handpiece is attached to the Tixel Console by an umbilical tube. The console touch screen is used to control the system parameters.
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