Cleared Traditional

K120938 - THE PL-1064 LASER SYSTEM

K120938 is an FDA 510(k) clearance for THE PL-1064 LASER SYSTEM, manufactured by Sheaumann Laser, Inc.. The device is a Class 2 General & Plastic Surgery device with product code PDZ cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K120938 · Sheaumann Laser, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
186d
Days
Class 2
Risk

K120938 is an FDA 510(k) clearance for the THE PL-1064 LASER SYSTEM. Classified as Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ), Class II - Special Controls.

Submitted by Sheaumann Laser, Inc. (Oviedo, US). The FDA issued a Cleared decision on September 24, 2012 after a review of 186 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 Sheaumann Laser, Inc. devices

FDA 510(k) Submission Details - K120938

510(k) Number K120938 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 22, 2012
Decision Date September 24, 2012
Days to Decision 186 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 115d · This submission: 186d
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
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