Cleared Traditional

Aspen Laser Systems Therapy Laser System

K150138 · Aspen Laser Systems, LLC · General & Plastic Surgery
May 2015
Decision
106d
Days
Class 2
Risk

About This 510(k) Submission

K150138 is an FDA 510(k) clearance for the Aspen Laser Systems Therapy Laser System, a Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (Class II — Special Controls, product code PDZ), submitted by Aspen Laser Systems, LLC (Reno, US). The FDA issued a Cleared decision on May 8, 2015, 106 days after receiving the submission on January 22, 2015. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4810.

Submission Details

510(k) Number K150138 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2015
Decision Date May 08, 2015
Days to Decision 106 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.).