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CoreLevee

FDA 510(k)

Class II (US FDA 510(k))

510(k) K213748

by Lutronic Corporation

Identifiers

510(k) Number
K213748 FDA 510(k)
FDA Product Code
NGX FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 890.5850 FDA 510(k)
Regulation Number
890.5850 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

CoreLevee is a Laser Therapy Device (product code NGX) designed for physical medicine applications, delivering focused light energy to promote tissue healing and reduce inflammation. It operates within the physical medicine category, utilizing laser technology to target specific areas for therapeutic effects. The device is classified as a Class 2 medical device under FDA regulations, ensuring compliance with stringent safety and performance standards. Its primary function aligns with non-invasive treatments for musculoskeletal and soft tissue conditions.

CoreLevee is supplied by Lutronic Corporation and cleared for use in the United States through the FDA’s Traditional 510(k) pathway, with clearance number K213748 granted on October 14, 2022. The device is intended for single-use or reusable applications, depending on manufacturer specifications, though sterility and reprocessing instructions must adhere to regulatory guidelines. No explicit MRI safety classification is provided in the data. Storage and handling follow standard medical device protocols to maintain efficacy and safety. Authorizations are limited to the stated FDA clearance; no additional regulatory approvals are referenced.

Frequently asked questions

What is the CoreLevee Laser Therapy Device used for?

The CoreLevee is designed for physical medicine applications, specifically to deliver focused light energy for promoting tissue healing and reducing inflammation. It targets musculoskeletal and soft tissue conditions, offering a non-invasive treatment option to support recovery and alleviate discomfort.

How is the CoreLevee supplied and what are its usage options?

CoreLevee is supplied by Lutronic Corporation and is cleared for use in the U.S. through the FDA’s Traditional 510(k) pathway. It can be used either as a single-use device or as a reusable device, depending on the manufacturer’s specifications. If reused, strict adherence to sterility and reprocessing guidelines is required to ensure safety and efficacy.

Is the CoreLevee sterile and how should it be stored?

The CoreLevee’s sterility depends on its intended use—single-use or reusable. For single-use applications, it is typically sterile upon packaging. For reusable applications, the device must undergo proper sterilization and reprocessing following regulatory guidelines. Storage should follow standard medical device protocols to maintain its efficacy and safety, as outlined by Lutronic Corporation.

What regulatory classification does the CoreLevee hold?

The CoreLevee is classified as a Class 2 medical device under FDA regulations, indicating it poses minimal risk and is subject to stringent safety and performance standards. Its FDA clearance (K213748) was granted through the Traditional 510(k) pathway, confirming its substantial equivalence to a predicate device in the physical medicine category.

Does the CoreLevee have any specific MRI safety information?

The provided data does not include explicit MRI safety classification for the CoreLevee. If MRI compatibility is a concern, users should consult Lutronic Corporation’s documentation or contact their technical support for detailed guidance on safe handling in MRI environments.

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: K213748 FDA 510 (k) - CoreLevee | Lutronic Corporation, CoreLevee (K213748) — FDA 510(k) | Innolitics, CoreLevee - FDA 510 (k) K213748 | Pure Global AI, Lutronic Corporation FDA 510 (k) Products - Latest 2025

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Lutronic Corporation

Sources (1)

  • FDA 510(k) K213748 24 fields · synced Oct 1, 2026