Cleared Traditional

AF Laser

K221363 · ShenB Co., Ltd. · General & Plastic Surgery

Jul 2022

Decision

70d

Days

Class 2

Risk

About This 510(k) Submission

K221363 is an FDA 510(k) clearance for the AF Laser, a Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (Class II — Special Controls, product code PDZ), submitted by ShenB Co., Ltd. (Seoul, KR). The FDA issued a Cleared decision on July 20, 2022, 70 days after receiving the submission on May 11, 2022. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K221363 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 11, 2022
Decision Date	July 20, 2022
Days to Decision	70 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.).