XTRAC Momentum Excimer Laser System

Strata Skin Sciences, Inc.

Country / region:United States (US)Submission type:Special

Product code GEX· 21 CFR 878.4810

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Company

United States (US)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K193478
Device name
XTRAC Momentum Excimer Laser System
Country / region
United States(US)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2019-12-16
Decision date
2020-01-14
Submission type
Special
Technology type
Other(AI inferred)
Clinical applications
Skin resurfacing
Primary application
Skin resurfacing
Classification source
AI classified

Indications for Use

UVB phototherapy for psoriasis, vitiligo, atopic dermatitis, and leukoderma.

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. Maximum pulse energy delivered to the patient's skin through the fiber optic cable and subsequent hand piece with skin contact tip is 15mJ per pulse or a fluence (radiant exposure) of 3.8 mJ/cm2 (non-ablating). The average power delivered to the patient's skin is limited to 6 Watts which is a balance between time to deliver a dose and skin heating effect. Accessories include different tip configurations: Standard Tip: Designed to pass a fixed 4cm2 square beam. Short Tip: For use with the iris diaphragm. Short Hair Scalp Tip: Similar to the standard tip but includes three hollow elongated 'teeth' to comb and part the hair in order to expose the scalp. Multi-Micro Dose (MMD) Tip: Provides four different dose levels with a single beam application, which can assist the physician in selection of the initial treatment dose.

Summary parsed at:2026-06-01 05:47:24 UTC

Predicate devices

2

K193478 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K193478 as a predicate