510(k) K211265

TFX-LT2000 Therapy Light by Toefx, Inc. — Product Code PDZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: November 17, 2022
Date Received: April 26, 2021
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device Class: Class II
Regulation Number: 878.4810
Review Panel: SU
Submission Type

For the temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes Trichophyton rubrum and T mentagrophytes, and/or yeasts Candida albicans, etc.).

Other clearances for product code PDZ

K253960 — Medicell Mycosis Laser (MCML24004) (March 9, 2026)
K241116 — Onycho Laser V (July 22, 2024)
K221363 — AF Laser (July 20, 2022)
K190034 — REMY Medical Therapy Laser System (May 15, 2019)
K153164 — LunulaLaser (June 3, 2016)
K150138 — Aspen Laser Systems Therapy Laser System (May 8, 2015)
K123014 — LITECURE THERAPY SYSTEM MODEL LTS-1500 (March 29, 2013)
K121508 — LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N (December 12, 2012)
K113843 — FREEDOM ND: YAG LASER SYSTEM (September 27, 2012)
K120938 — THE PL-1064 LASER SYSTEM (September 24, 2012)