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Micromanipulator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K924457

by Laser Engineering, Inc.

Identifiers

510(k) Number
K924457 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 Micromanipulator is a surgical accessory designed for use with CO2 laser systems. It facilitates precise control and positioning of the laser beam during multi-specialty surgical procedures.

This device is intended for use in all surgical settings and disciplines. It is supplied by Laser Engineering, Inc. and has received FDA 510k clearance.

Frequently asked questions

What is the primary function of the Micromanipulator?

The Micromanipulator is a surgical accessory engineered to provide precise control and accurate positioning of a CO2 laser beam during various multi-specialty surgical procedures.

In which clinical settings can this device be used?

This device is intended for use across all surgical settings and disciplines, allowing for versatile application in any environment where CO2 laser systems are utilized.

What is the regulatory status of the Micromanipulator?

The Micromanipulator has received FDA 510k clearance, which indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.

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: Laser cutting - Micromanipulator, Company - Micromanipulator, CO2 Innovation | Laser Engineering, Inc

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Laser Engineering, Inc.

Sources (1)

  • FDA 510(k) K924457 24 fields · synced Sep 25, 2026