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Medilas D Family Lasers

FDA 510(k)

Class II (US FDA 510(k))

510(k) K073427

by Dornier MedTech America, Inc.

Identifiers

510(k) Number
K073427 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 Medilas D Family Lasers are laser surgical devices designed for tissue ablation and coagulation in urological procedures, including plastic surgery applications. These devices utilize diode laser technology with a wavelength of 940 nm, delivering continuous wave output for precise medical interventions.

The Medilas D Family Lasers are supplied as reusable medical equipment, intended for use in clinical settings such as operating rooms or outpatient surgical facilities. They are regulated under FDA 510(k) clearance (K073427) as substantially equivalent to a predicate device, adhering to traditional review standards. No specific sterility or single-use designation is stated in the provided data.

Frequently asked questions

What types of medical procedures can the Medilas D Family Lasers be used for according to their intended purpose?

The Medilas D Family Lasers are designed specifically for tissue ablation and coagulation in urological procedures, with additional applications in plastic surgery. Their 940 nm diode laser technology is optimized for precise surgical interventions in these clinical settings, such as operating rooms or outpatient facilities.

Are the Medilas D Family Lasers single-use or reusable, and how does this affect their use in a clinical setting?

The Medilas D Family Lasers are not single-use devices; they are reusable medical equipment intended for repeated use in clinical environments like operating rooms or outpatient surgical facilities. This means they require proper cleaning, maintenance, and sterilization protocols between uses to ensure safety and performance.

What wavelength does the Medilas D Family Lasers use, and why is this important for its applications?

The Medilas D Family Lasers operate at a 940 nm wavelength, which is critical for their use in tissue ablation and coagulation. This wavelength is particularly effective for penetrating tissue while minimizing collateral damage, making it suitable for urological and plastic surgery procedures where precision is essential.

How were these lasers approved by the FDA, and what does the product code (GEX) indicate about their regulatory classification?

The Medilas D Family Lasers received FDA 510(k) clearance (K073427) under the Traditional Review pathway, demonstrating they are substantially equivalent to a predicate device. The product code GEX (General, Plastic Surgery) reflects their regulatory filing category, though their actual clinical indications extend to urology as well. This means the approval was based on safety and effectiveness comparisons to existing devices.

Since these lasers are reusable, what considerations should clinicians keep in mind regarding maintenance and longevity?

As reusable equipment, clinicians must follow the manufacturer’s guidelines for cleaning, calibration, and sterilization to ensure consistent performance and safety. The device’s longevity depends on proper maintenance, as laser systems can degrade over time with repeated use. Regular inspections and adherence to Dornier MedTech’s operational protocols will help sustain its effectiveness in clinical settings.

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: Medilas D Family Lasers, Including Medilas D Litebeam, Litebeam ..., Dornier MedTech - A Leading Urological Medical Device Company, Lasers & Fibers — Dornier MedTech Americas, Dornier MedTech - Medilas D MultiBeam - MedWrench

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Dornier MedTech America, Inc.

Sources (1)

  • FDA 510(k) K073427 24 fields · synced Oct 6, 2026