Cleared Traditional

K121508 - LIGHTWALKER AT LIGHTWALKER DT LIGHTWALK...

K121508 is an FDA 510(k) clearance for LIGHTWALKER AT LIGHTWALKER DT LIGHTWALK..., manufactured by Fotona D.D.. The device is a Class 2 General & Plastic Surgery device with product code PDZ cleared through the Traditional 510(k) pathway after a 205-day FDA review.

K121508 · Fotona D.D. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2012
Decision
205d
Days
Class 2
Risk

K121508 is an FDA 510(k) clearance for the LIGHTWALKER AT LIGHTWALKER DT LIGHTWALKER ST-E LIGHTWALKER ST-N. Classified as Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ), Class II - Special Controls.

Submitted by Fotona D.D. (Ljubljana, SI). The FDA issued a Cleared decision on December 12, 2012 after a review of 205 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 Fotona D.D. devices

FDA 510(k) Submission Details - K121508

510(k) Number K121508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2012
Decision Date December 12, 2012
Days to Decision 205 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 115d · This submission: 205d
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.

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All 9
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