Cleared Traditional

REMY Medical Therapy Laser System

K190034 · Footdocprenur, LLC · General & Plastic Surgery

May 2019

Decision

128d

Days

Class 2

Risk

About This 510(k) Submission

K190034 is an FDA 510(k) clearance for the REMY Medical Therapy Laser System, a Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (Class II — Special Controls, product code PDZ), submitted by Footdocprenur, LLC (Cherry Hill, US). The FDA issued a Cleared decision on May 15, 2019, 128 days after receiving the submission on January 7, 2019. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number	K190034 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 07, 2019
Decision Date	May 15, 2019
Days to Decision	128 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement

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.).