K211265 is an FDA 510(k) clearance for the TFX-LT2000 Therapy Light, a Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (Class II — Special Controls, product code PDZ), submitted by Toefx, Inc. (Hamilton, CA). The FDA issued a Cleared decision on November 17, 2022, 570 days after receiving the submission on April 26, 2021. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.
| 510(k) Number | K211265 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 26, 2021 |
| Decision Date | November 17, 2022 |
| Days to Decision | 570 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Statement |
| Product Code | PDZ — Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 878.4810 |
| Definition | 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.). |