Identifiers
- 510(k) Number
- K250189 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)
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.
Frequently asked questions
What is the AdvaTx laser system used for?
The AdvaTx is a dual-wavelength laser designed for dermatological and aesthetic procedures, utilizing wavelengths of 589nm and 1319nm to address various skin conditions and treatment goals.
How is the AdvaTx device supplied?
The AdvaTx is supplied as a complete laser system with no consumable components, manufactured by Advalight Aps in Bellerup, Denmark, and distributed under product code GEX.
What regulatory approvals does the AdvaTx have?
The AdvaTx has received FDA 510(k) clearance (K250189) as a traditional clearance device, classified under the General and Plastic Surgery advisory committee.
Can the AdvaTx be reused or is it single-use?
The device is designed for repeated use in clinical settings, as there are no single-use components mentioned in the provided specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: ADVATx Dual Wavelength Laser: 589/1319nm | Advalight, Advalight | ADVATx & ADVAFx Dermatology Lasers | US, About Us | Advalight — ADVATx Laser Innovator, K250189 FDA 510 (k) - AdvaTx | Advalight Aps
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K250189 | Class II | Active |
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Manufacturer
- Manufacturer
- Advalight Aps
Sources (1)
- FDA 510(k) K250189 24 fields · synced Sep 28, 2026