Cleared Traditional

K190034 - REMY Medical Therapy Laser System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K190034 · Footdocprenur, LLC · General & Plastic Surgery device
May 2019
Decision
128d
Days
Class 2
Risk

K190034 is an FDA 510(k) clearance for the REMY Medical Therapy Laser System. Classified as Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ), Class II - Special Controls.

Submitted by Footdocprenur, LLC (Cherry Hill, US). The FDA issued a Cleared decision on May 15, 2019 after a review of 128 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4810 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K190034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Regulatory Context
Review time vs. panel average
4d faster than avg
Panel avg: 132d · This submission: 128d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Device Class Class 2 - 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.).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.