Cleared Traditional

Onycho Laser V

K241116 · Terasysd&C, Inc. · General & Plastic Surgery

Jul 2024

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K241116 is an FDA 510(k) clearance for the Onycho Laser V, a Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (Class II — Special Controls, product code PDZ), submitted by Terasysd&C, Inc. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on July 22, 2024, 90 days after receiving the submission on April 23, 2024. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K241116 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 23, 2024
Decision Date	July 22, 2024
Days to Decision	90 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF

Device Classification

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.).