Cleared Traditional

K111483 - JOULE CLEARSENSE LASER SYSTEM

K111483 is an FDA 510(k) clearance for JOULE CLEARSENSE LASER SYSTEM, manufactured by Sciton, Inc. The device is a Class 2 General & Plastic Surgery device with product code PDZ cleared through the Traditional 510(k) pathway after a 190-day FDA review.

K111483 · Sciton, Inc · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2011
Decision
190d
Days
Class 2
Risk

K111483 is an FDA 510(k) clearance for the JOULE CLEARSENSE LASER SYSTEM. Classified as Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ), Class II - Special Controls.

Submitted by Sciton, Inc (Palo Alto, US). The FDA issued a Cleared decision on December 7, 2011 after a review of 190 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 Sciton, Inc devices

FDA 510(k) Submission Details - K111483

510(k) Number K111483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 31, 2011
Decision Date December 07, 2011
Days to Decision 190 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
75d slower than avg
Panel avg: 115d · This submission: 190d
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 11
Devices cleared under the same product code (PDZ) and FDA review panel - the closest regulatory comparables to K111483.
FREEDOM ND: YAG LASER SYSTEM
K113843 · Lutronic Corporation · Sep 2012
FOTONA XP ND: YAG LASER SYSTEM
K113702 · Fotona D.D. · Mar 2012
MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES
K113810 · Alma Lasers, Inc. · Mar 2012
COOLTOUCH
K103338 · New Star Lasers, Inc. · Nov 2011
CUTERA GENESISPLUS LASER SYSTEM
K103626 · Cutera, Inc. · Apr 2011