Skip to content

TFX-LT2000 Therapy Light

by Toefx, Inc.

510(k) K211265

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK211265 Date17 Nov 2022ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
PDZ
Device class
Class II
Regulation
21 CFR Part 878.4810
Advisory committee
General, Plastic Surgery
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 25 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Similar devices

Other devices filed under FDA product code PDZ (Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis).

Other devices from Toefx, Inc.