FDA Product Code PDZ: Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
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.).
Leading manufacturers include Terasysd&C, Inc. and Medicell Healthcare Co.,LTD.
FDA 510(k) Cleared Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis Devices (Product Code PDZ)
About Product Code PDZ - Regulatory Context
510(k) Submission Activity
19 total 510(k) submissions under product code PDZ since 2010, with 19 receiving FDA clearance (average review time: 204 days).
Submission volume has remained relatively stable over the observed period, with 2 submissions in the last 24 months.
FDA Review Time
Recent submissions under PDZ have taken an average of 90 days to reach a decision - down from 218 days historically, suggesting improved FDA processing for this classification.
PDZ devices are reviewed by the General & Plastic Surgery panel. Browse all General & Plastic Surgery devices →