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Alma Lasers Pixel Co2 Laser System, Delivery Device And Accessories

FDA 510(k)

Class II (US FDA 510(k))

510(k) K103501

by Alma Lasers, Inc.

Identifiers

510(k) Number
K103501 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)

The Pixel CO₂ Laser System is a fractional CO₂ laser device designed for soft tissue ablation, vaporization, excision, incision, and coagulation. It operates using carbon dioxide laser technology to deliver precise, customisable energy for resurfacing and tissue modification, primarily in dermatological and plastic surgery applications.

This system is supplied with delivery devices and accessories for use in surgical settings, including aesthetic surgery, podiatry, gynecology, neurosurgery, and orthopedic soft tissue procedures. It is intended for single-use or reusable components as specified by the manufacturer, with regulatory clearance under FDA 510(k) as a Special Submission (K103501) under the General, Plastic Surgery advisory committee. No additional sterility or MRI safety details are provided in the data.

Frequently asked questions

What types of medical procedures is the Pixel CO₂ Laser System primarily used for, and in which specialties?

The Pixel CO₂ Laser System is designed for soft tissue procedures like ablation, vaporization, excision, incision, and coagulation, with a focus on dermatological and plastic surgery. It is also approved for use in aesthetic surgery, podiatry, gynecology, neurosurgery, and orthopedic soft tissue procedures, making it versatile for various surgical settings.

How is the Pixel CO₂ Laser System supplied, and are the components single-use or reusable?

The system is supplied with delivery devices and accessories tailored for surgical use. The manufacturer specifies whether individual components are intended for single-use or can be reused, though this distinction is not detailed in the provided data. Always follow the manufacturer’s guidelines for proper use and reprocessing.

What regulatory pathway was followed for FDA clearance of this device, and what does that mean for its intended use?

The Pixel CO₂ Laser System received FDA clearance through a 510(k) Special Submission (K103501) under the General, Plastic Surgery advisory committee, with a decision of Substantially Equivalent (SESE). This means the FDA determined it is as safe and effective as a legally marketed predicate device for its intended uses, which include soft tissue procedures in dermatology, plastic surgery, and other specified specialties.

Are there any specific storage instructions or considerations for the Pixel CO₂ Laser System or its accessories?

The provided data does not include explicit storage instructions for the Pixel CO₂ Laser System or its accessories. However, as with most laser systems, proper handling—such as avoiding moisture, extreme temperatures, and contamination—is critical. Always refer to the manufacturer’s instructions for complete storage and maintenance guidelines.

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: Pixel CO2 - CO2 Fractional Laser Machine | Alma, alma-Portal | Universität Tübingen, Femilift Pixel CO2 System | Alma Lasers - almainc.com, Alma Pixel | Alma Lasers

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alma Lasers, Inc.

Sources (1)

  • FDA 510(k) K103501 24 fields · synced Sep 19, 2026