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Harmony 1064NM (ND:YAG) Modules

FDA 510(k)

Class II (US FDA 510(k))

510(k) K113810

by Alma Lasers, Inc.

Identifiers

510(k) Number
K113810 FDA 510(k)
FDA Product Code
PDZ 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 Harmony 1064nm (ND:YAG) Modules are a class II laser system designed for medical applications involving tissue interaction. These modules operate at a wavelength of 1064 nanometers, utilizing neodymium-doped yttrium aluminium garnet (ND:YAG) technology to deliver precise laser energy for therapeutic or cosmetic procedures. The device is intended for use in procedures where controlled thermal effects on tissue are required, such as temporary enhancement of nail clarity in patients with onychomycosis.

These modules are supplied as part of a medical laser system and are intended for single-use or reusable configurations, depending on the clinical setting and manufacturer guidelines. They are not classified as sterile devices but must be handled under aseptic conditions when used in direct patient contact. The modules are regulated under FDA 510(k) clearance (K113810) and fall under the product code PDZ, adhering to regulatory standards for lasers in general, plastic, and dermatological surgery. Storage and handling must comply with manufacturer instructions to ensure optimal performance and safety.

Frequently asked questions

What is the primary use of the Alma Lasers Harmony 1064nm ND:YAG Modules?

The Harmony 1064nm ND:YAG Modules are designed for medical procedures requiring controlled thermal effects on tissue. Their most specified application is temporary enhancement of nail clarity in patients with onychomycosis, leveraging the 1064nm wavelength for targeted treatment. The wavelength is chosen for its ability to penetrate tissue effectively while minimizing collateral damage, making it suitable for dermatological and cosmetic interventions.

Are the Harmony 1064nm ND:YAG Modules sterile, and how should they be handled?

These modules are not classified as sterile devices. However, they must be handled under aseptic conditions when used in direct patient contact to ensure safety and prevent contamination. Proper sterilization or disinfection protocols must be followed as per manufacturer guidelines, especially if configured for reusable use in clinical settings.

Can the Harmony 1064nm ND:YAG Modules be reused, or are they intended for single-use?

The modules are supplied as part of a system that can be configured for either single-use or reusable applications, depending on the clinical setting and adherence to manufacturer instructions. Reusability requires strict adherence to cleaning, sterilization, and maintenance protocols to ensure performance and safety. Always follow the manufacturer’s guidelines to determine the appropriate use case for your facility.

What regulatory approvals apply to the Alma Lasers Harmony 1064nm ND:YAG Modules?

The Harmony 1064nm ND:YAG Modules are regulated under the FDA’s 510(k) clearance pathway, with clearance number K113810. They fall under product code PDZ and are classified as Class II devices. This clearance indicates that the device is deemed substantially equivalent to a legally marketed predicate device, meeting regulatory standards for lasers in general, plastic, and dermatological surgery applications.

How should the Harmony 1064nm ND:YAG Modules be stored to maintain performance?

Storage and handling of these modules must comply with the manufacturer’s instructions to ensure optimal performance and safety. This typically includes protecting the device from physical damage, extreme temperatures, and environmental contaminants. If the modules are reusable, they should be stored in a clean, dry environment and follow any specific storage protocols outlined by Alma Lasers to preserve functionality and sterility when prepared for use.

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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Alma Lasers, Inc.

Sources (1)

  • FDA 510(k) K113810 24 fields · synced Oct 1, 2026