Cleared Traditional

K153164 - LunulaLaser

K153164 is an FDA 510(k) clearance for LunulaLaser, manufactured by Erchonia Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PDZ cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K153164 · Erchonia Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
214d
Days
Class 2
Risk

K153164 is an FDA 510(k) clearance for the LunulaLaser. Classified as Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ), Class II - Special Controls.

Submitted by Erchonia Medical, Inc. (Mckinney, US). The FDA issued a Cleared decision on June 3, 2016 after a review of 214 days - an extended review cycle.

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.

View all Erchonia Medical, Inc. devices

FDA 510(k) Submission Details - K153164

510(k) Number K153164 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2015
Decision Date June 03, 2016
Days to Decision 214 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d slower than avg
Panel avg: 115d · This submission: 214d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

PDZ Device Classification - Class 2, Special Controls

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.

Regulatory Peers - PDZ Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis

All 12
Devices cleared under the same product code (PDZ) and FDA review panel - the closest regulatory comparables to K153164.
TFX-LT2000 Therapy Light
K211265 · Toefx, Inc. · Nov 2022
AF Laser
K221363 · ShenB Co., Ltd. · Jul 2022
REMY Medical Therapy Laser System
K190034 · Footdocprenur, LLC · May 2019
LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N
K121508 · Fotona D.D. · Dec 2012
FREEDOM ND: YAG LASER SYSTEM
K113843 · Lutronic Corporation · Sep 2012
FOTONA XP ND: YAG LASER SYSTEM
K113702 · Fotona D.D. · Mar 2012