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Adler MicroMed Laser Surgery Fibers (K152417)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K152417

by Adler MicroMed, Inc.

Identifiers

510(k) Number
K152417 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 Adler MicroMed Laser Surgery Fibers (K152417) are laser delivery fibers designed for surgical applications. These fibers facilitate precise laser energy transmission across a broad wavelength range (450 nm to 2100 nm) for use in various medical specialties, including general surgery, urology, and dermatology, among others. They are engineered to operate in both contact and non-contact modes, enabling flexibility in surgical techniques.

These fibers are single-use, sterile devices supplied for medical laser surgery procedures. They are classified as FDA Class II Medical Devices under the 510(k) clearance process, with a Substantially Equivalent (SESE) determination by the General Plastic Surgery Advisory Committee. Storage and handling must comply with sterile medical device protocols to ensure clinical safety and efficacy.

Frequently asked questions

Are these fibers reusable or designed for single-use in surgical procedures, and why does that matter?

The Adler MicroMed Laser Surgery Fibers are single-use only, as explicitly stated in the device description. This matters because single-use fibers eliminate the risk of cross-contamination between patients, reducing infection risks and ensuring sterile surgical environments. Reusing fibers could compromise sterility and potentially introduce pathogens, which is why adherence to single-use protocols is critical for clinical safety.

What types of surgical specialties can these fibers be used in, and how does their wavelength range support that flexibility?

These fibers are designed for general surgery, urology, dermatology, and other specialties where laser precision is required. Their broad wavelength range (450 nm to 2100 nm) allows them to transmit laser energy compatible with multiple surgical lasers, enabling versatility in procedures like tissue ablation, coagulation, or vaporization. The flexibility in wavelength support ensures compatibility with various laser systems used across these specialties.

How should these fibers be stored, and why is proper storage important for maintaining their performance?

The fibers must be stored following sterile medical device protocols, though specific packaging details aren’t provided, standard sterile barrier packaging (e.g., sealed pouches) is implied. Proper storage is critical because it preserves sterility, prevents contamination, and ensures the fibers remain intact for their intended single-use application. Compromised storage could lead to microbial growth or physical damage, compromising both safety and efficacy during surgery.

Can these fibers be used in both direct (contact) and indirect (non-contact) laser applications, and what does that mean for surgical techniques?

Yes, the fibers are engineered for both contact and non-contact modes, meaning they can deliver laser energy either directly to tissue (e.g., for precise cutting or ablation) or at a distance (e.g., for broader tissue effects like coagulation). This dual-mode capability offers surgeons flexibility in technique, allowing them to adapt to the specific requirements of a procedure—whether minimal tissue trauma is needed or broader treatment areas must be addressed.

What does the FDA’s ‘Substantially Equivalent’ (SESE) determination mean for clinicians considering this device?

The SESE determination by the FDA’s General Plastic Surgery Advisory Committee indicates that the Adler MicroMed Laser Surgery Fibers are deemed ‘substantially equivalent’ to a legally marketed predicate device in terms of technology and performance. For clinicians, this means the device has undergone regulatory review to confirm it meets established safety and effectiveness standards, providing confidence in its clinical use without requiring new clinical trials. It does not imply innovation but rather continuity with existing, approved technologies.

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: Adler MicroMed Laser Surgery Fibers (K152417) - Innolitics, Adler MicroMed, Adler MicroMed Laser Surgery Fibers, Adler MicroMed Laser Surgery Fiber — FDA Class II Medical Device ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Adler MicroMed, Inc.

Sources (1)

  • FDA 510(k) K152417 24 fields · synced Sep 19, 2026