Cleared Traditional

K110375 - BLUESHINE'S GOLD SERIES

K110375 is an FDA 510(k) clearance for BLUESHINE'S GOLD SERIES, manufactured by Blueshine Srl. The device is a Class 2 General & Plastic Surgery device with product code PDZ cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K110375 · Blueshine Srl · General & Plastic Surgery device
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Feb 2012
Decision
379d
Days
Class 2
Risk

K110375 is an FDA 510(k) clearance for the BLUESHINE'S GOLD SERIES. Classified as Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis (product code PDZ), Class II - Special Controls.

Submitted by Blueshine Srl (Mestre(Ve), IT). The FDA issued a Cleared decision on February 23, 2012 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Blueshine Srl devices

FDA 510(k) Submission Details - K110375

510(k) Number K110375 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 09, 2011
Decision Date February 23, 2012
Days to Decision 379 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
264d slower than avg
Panel avg: 115d · This submission: 379d
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 K110375.
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
JOULE CLEARSENSE LASER SYSTEM
K111483 · Sciton, Inc · Dec 2011
COOLTOUCH
K103338 · New Star Lasers, Inc. · Nov 2011
CUTERA GENESISPLUS LASER SYSTEM
K103626 · Cutera, Inc. · Apr 2011