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FDA 510(k)

XTRAC Momentum Excimer Laser System

K-Number: K193478 · 2020-01-14

ApplicantStrata Skin Sciences, Inc.
Decision Date2020-01-14
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

XTRAC Momentum Excimer Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Strata Skin Sciences, Inc.. It received FDA 510(k) clearance on 2020-01-14 under 510(k) number K193478. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XTRAC Momentum Excimer Laser System?

XTRAC Momentum Excimer Laser System is a medical device that received FDA 510(k) clearance on 2020-01-14. The listed applicant is Strata Skin Sciences, Inc.. The 510(k) number is K193478.

When did XTRAC Momentum Excimer Laser System receive FDA 510(k) clearance?

XTRAC Momentum Excimer Laser System received FDA 510(k) clearance on 2020-01-14, under 510(k) number K193478.

Who is the listed applicant for XTRAC Momentum Excimer Laser System?

The FDA 510(k) record lists Strata Skin Sciences, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XTRAC Momentum Excimer Laser System?

The FDA product code for XTRAC Momentum Excimer Laser System is GEX. This falls under the Gastroenterology category.

Other records listing Strata Skin Sciences, Inc. as applicant

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Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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