Cleared Traditional

K123014 - LITECURE THERAPY SYSTEM MODEL LTS-1500

K123014 is an FDA 510(k) clearance for LITECURE THERAPY SYSTEM MODEL LTS-1500, manufactured by Litecure, LLC. The device is a Class 2 General & Plastic Surgery device with product code PDZ cleared through the Traditional 510(k) pathway after a 183-day FDA review.

K123014 · Litecure, LLC · General & Plastic Surgery device
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Mar 2013
Decision
183d
Days
Class 2
Risk

K123014 is an FDA 510(k) clearance for the LITECURE THERAPY SYSTEM MODEL LTS-1500. Classified as Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ), Class II - Special Controls.

Submitted by Litecure, LLC (Newark, US). The FDA issued a Cleared decision on March 29, 2013 after a review of 183 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 Litecure, LLC devices

FDA 510(k) Submission Details - K123014

510(k) Number K123014 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2012
Decision Date March 29, 2013
Days to Decision 183 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
68d slower than avg
Panel avg: 115d · This submission: 183d
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

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