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Guardian 1000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K151629

by Quanta System Spa

Identifiers

510(k) Number
K151629 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 Guardian 1000 is a 980 nm GaAlAs infrared laser surgical system designed for use in general surgery, plastic surgery, and dermatology. It delivers energy through quartz optical fibers and various handpieces to perform surgical procedures.

The device console features power electronics, a cooling system utilizing Peltier cells and fans, and a touch screen interface to control laser emission and source temperature. This device has received FDA 510(k) clearance under K151629.

Frequently asked questions

What is the primary function of the Guardian 1000?

The Guardian 1000 is a 980 nm GaAlAs infrared laser surgical system. It is designed to perform surgical procedures across the fields of general surgery, plastic surgery, and dermatology by delivering energy through quartz optical fibers and specialized handpieces.

How is laser emission controlled on this device?

The device features a dedicated touch screen interface that allows the clinician to control laser emission and monitor the source temperature. The console also integrates power electronics and a cooling system that utilizes Peltier cells and fans to maintain operational stability.

What is the regulatory status of the Guardian 1000?

The Guardian 1000 has received FDA 510(k) clearance under K151629. This indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices for use in general and plastic surgery.

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: Guardian 1000 (K151629) — FDA 510 (k) | Innolitics, PDF THIS IS A TEMPLATE - Food and Drug Administration, Guardian 1000 510 (k) FDA Premarket Notification K151629 Quanta System SpA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Quanta System Spa

Sources (1)

  • FDA 510(k) K151629 24 fields · synced Sep 23, 2026