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510(k) Data Aggregation
K Number
K193478Device Name
XTRAC Momentum Excimer Laser System
Manufacturer
Strata Skin Sciences, Inc.
Date Cleared
2020-01-14
(29 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Strata Skin Sciences, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma.
Device Description
The Momentum is a self-contained compact laser light source that operates on standard AC supply power requiring no special power or cooling considerations. A protective interlocked housing encloses the laser source, electronics, and gas storage and distribution system. The XTRAC Momentum Model AL10000 comes in two spatial configurations: a horizontal (Velocity)configuration and a vertical (upright / Momentum) configuration.
A core element of both the Momentum excimer laser and the Velocity is a sealed chamber containing a mixture of pressurized Neon, Xenon, and HCl gases. High-voltage electrical discharges into the gas mixture create unstable XeCl molecules, which dissociate rapidly, creating monochromatic ultraviolet light at a wavelength of 308 nm. The electrical discharges are repeated in a fast sequence, producing a train of light pulses of a nominal duration of 30ns each. The timing of electrical discharges and energy of the produced light are constantly monitored by an on-board microprocessor to ensure safety.
Using a set of optical devices such as mirrors, shutters, lenses, and optic fibers, the produced light is focused and directed by the user to skin areas affected by disease. Each dose delivered by the system is composed of multiple laser pulses delivered at a preset repetition rate for a duration that is managed by the system processor.
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K Number
K181480Device Name
MMD Tip
Manufacturer
Strata Skin Sciences, Inc.
Date Cleared
2018-08-01
(57 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Strata Skin Sciences, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate the maximum non-blistering dose for a particular patient.
The Multi-Micro Dose (MMD) Tip accessory is indicated for use in conjunction with the XTRAC laser system to filter the NB-UVB light at delivery in order to calculate and individualize the maximum non-blistering dose for a particular patient.
Device Description
The subject device is the Multi-Micro Dose ("MMD") Tip.
The Multi-Micro Dose ("MMD") tip provides another method, separate of the MED mode, for determining the Optimal Therapeutic Dose ("OTD") for each patient. The OTD is the power setting on the XTRAC Phototherapy system customized for each patient that enables the user to provide patient specific treatment doses. As an alternative to the trial and error method of the MED mode, using the MMD Tip can often determine the optimal XTRAC power setting with a single test application.
The MMD Tip filters and reduces the laser output, providing four different dose levels in a single application. The reaction of the target area to the different dose levels assists in determining the patient specific Optimal Therapeutic Dose ("OTD").
The MMD Tip design places four (5mm x 5mm) square filters in the laser aperture.
The MMD Tip design is constructed of similar materials and components as the predicate tip. It connects to the XTRAC hand-piece in the same manner as the standard Tips of the XTRAC system.
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