← Back to catalogue

Quanta Cyber Tm 150W

FDA 510(k)

Class II (US FDA 510(k))

510(k) K102749

by Quanta System Spa

Identifiers

510(k) Number
K102749 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 Quanta Cyber Tm 150W is a high power Thulium surgical laser system. It is designed for use in urology treatments, including BPH, as well as open, laparoscopic, or endoscopic soft tissue surgery to perform excision, resection, ablation, vaporization, coagulation, and hemostasis.

This device is authorized via FDA 510K clearance. It is intended for use in medical specialties including general and plastic surgery.

Frequently asked questions

What clinical procedures can be performed with the Quanta Cyber Tm 150W?

This laser system is indicated for a variety of soft tissue surgeries, including open, laparoscopic, and endoscopic procedures. It is specifically designed for urology treatments such as BPH, and it supports surgical tasks including excision, resection, ablation, vaporization, coagulation, and hemostasis.

What is the regulatory status of the Quanta Cyber Tm 150W?

The Quanta Cyber Tm 150W is authorized via FDA 510K clearance, identified by K-number K102749. This indicates that the device has been determined to be substantially equivalent to a legally marketed predicate device.

Which medical specialties is this laser system intended for?

The device is intended for use in several medical specialties, primarily focusing on urology treatments, as well as 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: Cyber TM - Thulium Laser Systems| Quanta System, Cyber TM - Thulium Laser Systems| Quanta System, PDF Quanta System laser Cyber TM - medicom.cz, PDF SUMMARY I''9 Title: Quanta System Cyber Tmn 150W m9' DEC

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
Quanta System Spa

Sources (1)

  • FDA 510(k) K102749 24 fields · synced Sep 21, 2026