TFX-LT2000 Therapy Light
FDA 510(k)Class II (US FDA 510(k))
by Toefx, Inc.
Identifiers
- 510(k) Number
- K211265 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 TFX-LT2000 Therapy Light is a device for the temporary increase of clear nail in patients with onychomycosis. It uses dual-wavelength light to destroy fungal pathogens and support natural healing. The device is designed for use in clinic settings and features a built-in 12-minute timer.
The TFX-LT2000 Therapy Light is a Class II medical device with FDA 510(k) clearance (K211265). It is supplied as a portable device with a sleek design. The device is intended for use in general and plastic surgery settings and is regulated under product code PDZ.
Frequently asked questions
What is the TFX-LT2000 Therapy Light used for?
The TFX-LT2000 Therapy Light is designed for the temporary increase of clear nail in patients with onychomycosis. It uses dual-wavelength light to destroy fungal pathogens and support natural healing in clinical settings.
How is the TFX-LT2000 Therapy Light supplied?
The TFX-LT2000 Therapy Light is supplied as a portable device with a sleek design. It features a built-in 12-minute timer and is intended for use in general and plastic surgery settings.
What is the regulatory status of the TFX-LT2000 Therapy Light?
The TFX-LT2000 Therapy Light is a Class II medical device with FDA 510(k) clearance (K211265). It is regulated under product code PDZ and was cleared through the traditional pathway with a decision code of SESE.
Can the TFX-LT2000 Therapy Light be reused or is it single-use?
The device description does not specify whether the TFX-LT2000 Therapy Light is designed for single-use or multiple uses. As a portable device with a built-in timer, it appears to be intended for repeated clinical applications rather than disposable 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. Sources consulted: ToeFX Therapy Light - ToeFX, ToeFX, TFX-LT2000 Therapy Light (K211265) — FDA 510 (k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211265 | Class II | Active |
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Manufacturer
- Manufacturer
- Toefx, Inc.
Sources (1)
- FDA 510(k) K211265 24 fields · synced Sep 25, 2026