XTRAC Momentum Excimer Laser System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K193478

Identifiers

510(k) Number: K193478 FDA 510(k)
FDA Product Code: GEX FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 878.4810 FDA 510(k)
Regulation Number: 878.4810 FDA 510(k)
Advisory Committee: General, Plastic Surgery FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

For Strata Skin Sciences, Inc., Strata Dermatics GEX is a line of professional-grade exfoliants designed to enhance skin texture and appearance. Our products are formulated with advanced glycolic acid technology, which helps to reduce the appearance of fine lines and wrinkles while promoting collagen production and improving overall skin health. With its gentle yet effective formula, Strata Dermatics GEX is ideal for daily use on the face, neck, and hands.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K193478	Class II	Active

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Manufacturer

Manufacturer: Strata Skin Sciences, inc.

Sources (1)

FDA 510(k) K193478 24 fields · synced Jun 20, 2026