← Back to catalogue

MegaBeam Reusable Fiber Optic Handpiece and Needles

FDA 510(k)

Class II (US FDA 510(k))

510(k) K980389

by Ceram Optec, Inc.

Identifiers

510(k) Number
K980389 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 MegaBeam Reusable Fiber Optic Handpiece and Needles is a powered laser surgical instrument designed for general and plastic surgery applications. It delivers laser energy through a reusable fiber optic handpiece and interchangeable needles, enabling precise tissue ablation or coagulation in surgical procedures.

This device is intended for reusable use and includes needles with angled tips at 0°, 15°, 30°, and 70°. Supplied sterile, it is regulated under FDA 510(k) clearance (K980389) and falls under product code GEX, with classification under regulation 878.4810. Storage and handling must comply with manufacturer guidelines to maintain sterility and functionality.

Frequently asked questions

Is the MegaBeam handpiece designed for single-use or can it be reused in multiple procedures?

The MegaBeam Reusable Fiber Optic Handpiece is explicitly designed for reusable use, as stated in its name and description. This means it can be sterilized and used across multiple surgical procedures, provided proper cleaning, maintenance, and storage protocols are followed to preserve its functionality and sterility.

What needle tip angles are available for the MegaBeam system, and how might they affect surgical precision?

The MegaBeam system includes interchangeable needles with angled tips at 0°, 15°, 30°, and 70°. These angles allow surgeons to tailor the laser delivery to specific surgical needs, enabling precise tissue ablation or coagulation in confined or angled spaces, depending on the procedure requirements.

How is the MegaBeam device supplied, and what does that mean for its initial use in a surgical setting?

The MegaBeam Reusable Fiber Optic Handpiece and Needles are supplied sterile, meaning they are ready for immediate use upon receipt, eliminating the need for initial sterilization before the first procedure. This ensures a clean starting point while still requiring adherence to manufacturer guidelines for ongoing sterilization and maintenance.

What regulatory pathway was followed for FDA clearance of the MegaBeam device, and what does that imply about its safety and equivalence?

The MegaBeam device received FDA 510(k) clearance (K980389) under the Traditional 510(k) review pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. This implies that the FDA determined it has the same intended use and technological characteristics as a legally marketed device, ensuring it meets applicable safety and effectiveness requirements for general and plastic surgery applications.

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: Megabeam Reusable Fiber Optic Handpiece and Needles, Megabeam Reusable Fiber Optic Handpiece and Needles, MEGABEAM REUSABLE FIBER OPTIC HANDPIECE AND NEEDLES… - FDA.report, Reusable Megabeam Fiber Optic Delivery System

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Ceram Optec, Inc.

Sources (1)

  • FDA 510(k) K980389 24 fields · synced Sep 19, 2026