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510(k) Data Aggregation
K Number
K980784Device Name
SURETOUCH
Manufacturer
SAHAR TECHNOLOGIES, INC.
Date Cleared
1998-04-29
(58 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SAHAR TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SureTouch will be used to manipulate and place a pulsed and/or CW laser beam for use in dermatology for treatment of any soft tissue, including ablation, vaporization, and coagulation of soft tissue on the skin.
Device Description
Adding the SureTouch to a laser will convert the system into a sophisticated, easy to use aestheric surgery tool that can perform the widest range of cosmetic procedures. SureTouch may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where of micro-ablation is required. SureTouch introduces an extra dimension of control for precise tissue removal. The SureTouch aiming beam mode visually displays the area about to be treated on the tissue. While watching the aiming beam, the physicians can change the shapes and sizes. The aiming beam outline will change, continuously displaying the area that is about to be treated.
Filling in the displayed area is performed using a precise microprocessor control motion that deflects the laser beam on the tissue to ensure maximum accuracy and homogeneity. The SureTouch coordinates the laser emission while leaving the physician in full control of laser output at all times.
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K Number
K971024Device Name
SOFTSCAN
Manufacturer
SAHAR TECHNOLOGIES, INC.
Date Cleared
1997-06-17
(89 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SAHAR TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SoftScan will be used to manipulate and place a pulsed and/or CW laser beam for use in Dermatology for treatment of any soft tissue, including, ablation, vaporization and coagulation of soft tissue on the skin.
Device Description
Adding the SoftScan to any laser will convert the system into a sophisticated easy to use aesthetic surgery tool that can perform the widest range of cosmetic procedures. SoftScan may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where layer by layer of micro-ablation is required. SoftScan introduces an extra dimension of control for precise tissue removal using lower power than previously thought possible. The SoftScan aiming beam mode visually displays the area about to be treated on the tissue. While watching the aiming beam, the physician can change the shapes and sizes he selects to use. The aiming beam outline will change in a concurrently to continuously display the area that is about to be treated.
Filling the area is done using a precise computer control motion that deflects the laser beam on the tissue to ensure maximum accuracy and homogeneity. Coordinating the laser emission is done by the SoftScan while leaving the physician in full control of laser emission at all times.
SoftScan is a hand held device that is flexible enough to allow the physician the freedom to choose the area of treatment without being restricted by the system.
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K Number
K964684Device Name
SOFTOUCH
Manufacturer
SAHAR TECHNOLOGIES, INC.
Date Cleared
1997-02-14
(84 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
SAHAR TECHNOLOGIES, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Soft tissue treatments and in particular skin treatments require a device that can cover large and variable areas in a safe and homogeneous way. The SofTouch provides the ability to cover large and small areas of soft tissue while having perfect control of the emission placement and the emission reproducibility. The ability of the physician to identify the area to be treated by watching the aiming beam, while controlling the shape and the size that best fits the treated area will enhance the precision and safety of the treatment. The timing of the emission placement on the tissue is done by the SofTouch hardware and software to avoid errors and to increase precision and homogeneity. SofTouch is a hand held device that is flexible enough to allow the physician the freedom to choose the area of treatment without being restricted by the system.
Device Description
Adding the SofTouch to any laser will convert the system into a sophisticated easy to use aesthetic surgery tool that can perform the widest range of cosmetic procedures. SofTouch may be used for a variety of soft tissue ablation procedures, including aesthetic laser surgery where layer by layer of micro-ablation is required. SofTouch introduces an extra dimension of control for precise tissue resnoval using lower power than previously thought possible. The SofTouch aiming beam mode visually displays the area about to be treated on the tisme. While watching the aiming beam, the physician can change the shapes and sizes he selects to use. The aiming beam outline will change in a concurrently to continuously display the area that is about to be treated.
Filling the area is done using a precise computer control motion that deflects the laser beam on the tissue to ensure maximum accuracy and homogeneity. Coordinating the laser emission is done by the SofTouch while leaving the physician in full control of laser emission at all times.
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