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Trimedyne Model 1210 Omnipulse Holmium Laser Syst

FDA 510(k)

Class II (US FDA 510(k))

510(k) K922496

by Trimedyne, Inc.

Identifiers

510(k) Number
K922496 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 Trimedyne Model 1210 OmniPulse Holmium Laser System is a pulsed, solid-state Holmium:YAG laser (product code: GEX) designed for surgical applications. It emits infrared energy at a wavelength of 2.1 micrometers, enabling precise tissue ablation and coagulation. This device is classified under general and plastic surgery procedures, leveraging holmium laser technology for its cutting and vaporising capabilities. Its pulsed output allows controlled energy delivery to hard tissues while minimising collateral damage to surrounding soft tissues.

The Model 1210 is supplied as a reusable medical device, intended for use in clinical settings where holmium laser surgery is performed. It operates with disposable/reusable accessories, including laser fibers and handpieces, and requires proper handling and maintenance per manufacturer guidelines. The system is FDA-cleared under a 510(k) submission (K922496) as substantially equivalent to a predicate device, with no explicit MRI safety or sterility specifications noted in the available data. Storage and usage must comply with standard laser safety protocols and regulatory requirements for Class II moderate-risk devices.

Frequently asked questions

What types of surgical procedures is the Trimedyne Model 1210 OmniPulse Holmium Laser System primarily used for?

The Trimedyne Model 1210 is designed for surgical applications in general and plastic surgery, leveraging its 2.1-micrometer infrared wavelength to enable precise tissue ablation and coagulation. Its pulsed output is particularly effective for cutting and vaporizing hard tissues while minimizing damage to surrounding soft tissues, making it suitable for procedures where controlled energy delivery is critical.

Is the Trimedyne Model 1210 OmniPulse Holmium Laser System reusable, or does it require single-use components?

The Trimedyne Model 1210 itself is a reusable medical device, intended for clinical settings where holmium laser surgery is performed. However, it operates with disposable or reusable accessories, including laser fibers and handpieces, which must be handled and maintained according to the manufacturer’s guidelines to ensure safety and performance.

What safety considerations should be taken into account when storing or using this laser system?

Since the Trimedyne Model 1210 is classified as a Class II moderate-risk device, storage and usage must comply with standard laser safety protocols. While no explicit MRI safety or sterility specifications are noted, proper handling, maintenance, and adherence to regulatory requirements—including those for pulsed holmium laser systems—are essential to prevent hazards and ensure effective operation.

How does the pulsed output of this laser system benefit surgical precision compared to continuous-wave lasers?

The pulsed output of the Trimedyne Model 1210 allows for controlled energy delivery, reducing collateral damage to surrounding soft tissues while effectively cutting and vaporizing hard tissues. This makes it particularly advantageous in surgeries requiring precision, such as those in general and plastic surgery, where minimizing thermal spread is critical.

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: Home | Trimedyne, Trimedyne® 1210 OmniPulse™ Holmium Laser System, Omnipulse Holmium Laser System Model 1210, Omnipulse-max Holmium Laser ..., Products | Trimedyne

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Trimedyne, Inc.

Sources (1)

  • FDA 510(k) K922496 24 fields · synced Sep 20, 2026