AdvaTx Dual-Wavelength Laser Dermatology Device

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK250189	Date1 Apr 2025Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K250189

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K250189
FDA product code: GEX

Device class: Class II
Regulation: 21 CFR Part 878.4810
Advisory committee: General, Plastic Surgery
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Advatx K132976 17 Apr 2014 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

AdvaTx is a dual‑wavelength laser operating at 589 nm and 1319 nm, designed for dermatological and aesthetic procedures. The system delivers two distinct wavelengths to address a range of skin conditions and treatment goals.

The device is FDA‑510(k) cleared (K250189) and marketed by Advalight Aps, located in Bellerup, Denmark. It is supplied under product code GEX and is regulated as a traditional clearance, with no consumable components noted in the provided data.

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