Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

PDZ · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4810

Classification

FDA Product Code: PDZ
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 878.4810
Review panel: SU
Medical specialty: General, Plastic Surgery
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: N

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.).

Market data

Cleared 510(k) submissions: 19
Registered establishments: 19

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown