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FDA 510(k)

Fraxel® FTX Laser System

K-Number: K242142 · 2024-08-21

ApplicantSolta Medical
Decision Date2024-08-21
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Fraxel® FTX Laser System is a medical device manufactured by Solta Medical. It received FDA 510(k) clearance on 2024-08-21 under approval number K242142. 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 Fraxel® FTX Laser System?

Fraxel® FTX Laser System is a medical device that received FDA 510(k) clearance on 2024-08-21. It is manufactured by Solta Medical. The 510(k) number is K242142.

When was Fraxel® FTX Laser System approved by the FDA?

Fraxel® FTX Laser System received FDA 510(k) clearance on 2024-08-21, under approval number K242142.

What company makes Fraxel® FTX Laser System?

Fraxel® FTX Laser System is manufactured by Solta Medical.

What is the FDA product code for Fraxel® FTX Laser System?

The FDA product code for Fraxel® FTX Laser System is GEX. This falls under the Gastroenterology category.

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Related PubMed Literature

PMID: 40407411 A data augmentation approach for an automatic speech recognition system using laser Doppler vibrometer technology. JASA express letters (2025)

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Official Source

View on FDA Database →

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

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