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Naturalase CO2 Laser System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110333

by Focus Medical, LLC

Identifiers

510(k) Number
K110333 FDA 510(k)
FDA Product Code
ONG 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 Naturalase CO2 Laser System is a Powered Laser Surgical Instrument with Microbeam Fractional Output, classified as a Class II device under FDA regulation 878.4810. This device delivers precise, fractional CO2 laser energy for controlled ablation, resurfacing, or coagulation of soft tissue in dermatological and plastic surgery applications. Its fractional technology enables targeted treatment with reduced thermal damage to surrounding tissue, enhancing procedural outcomes and patient recovery.

The system is supplied as a reusable medical device and is intended for use in controlled clinical settings, such as surgical suites or dermatology clinics. It requires proper training and adherence to sterile techniques, as it involves direct tissue interaction. The device is authorized under FDA 510(k) clearance (K110333) for general and plastic surgery applications, with no specific MRI safety restrictions noted. Storage and maintenance must comply with manufacturer guidelines to ensure operational integrity and patient safety.

Frequently asked questions

What types of procedures is the Naturalase CO2 Laser System designed to assist with, and how does its fractional technology benefit patients?

The Naturalase CO2 Laser System is designed for dermatological and plastic surgery applications, specifically for controlled ablation, resurfacing, or coagulation of soft tissue. Its fractional technology delivers precise laser energy in targeted microbeams, reducing thermal damage to surrounding tissue compared to traditional methods. This approach enhances procedural outcomes by promoting faster healing and minimizing scarring or downtime for patients.

Is the Naturalase CO2 Laser System intended for single-use or reusable applications, and what considerations should be taken for its maintenance?

The Naturalase CO2 Laser System is supplied as a reusable medical device, meaning it is designed for repeated use in controlled clinical settings like surgical suites or dermatology clinics. Proper training and adherence to sterile techniques are required due to its direct tissue interaction. Maintenance must follow manufacturer guidelines to ensure operational integrity and patient safety, as outlined in the device’s instructions.

What regulatory pathway was followed for the Naturalase CO2 Laser System, and what does this mean for its use in clinical settings?

The Naturalase CO2 Laser System received FDA clearance through a 510(k) submission (K110333), classified as a Class II device under regulation 878.4810. This pathway confirms it is deemed substantially equivalent to a legally marketed predicate device, allowing its use in clinical settings for general and plastic surgery applications. The clearance does not impose specific MRI safety restrictions, but standard surgical precautions and sterile protocols remain mandatory.

How does the fractional output of the Naturalase CO2 Laser System differ from conventional CO2 laser systems, and what clinical advantages does this provide?

The Naturalase CO2 Laser System’s fractional output delivers microbeam laser energy, creating precise, localized treatment zones while sparing adjacent tissue. Unlike conventional CO2 lasers, which may cause broader thermal damage, this targeted approach reduces collateral effects, improves healing, and shortens recovery time for patients undergoing soft tissue procedures like resurfacing or coagulation.

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: NaturaLase CO2 — FOCUS MEDICAL, NATURALASE CO2 LASER SYSTEM by FOCUS MEDICAL, LLC. | FDA 510 (k) Summary, Focus Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Focus Medical, LLC

Sources (1)

  • FDA 510(k) K110333 24 fields · synced Sep 19, 2026